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A double-blind randomized controlled trial of normal

saline, lactated Ringers, and hypertonic saline nasal


irrigation solution after endoscopic sinus surgery
Tsu-Hui (Hubert) Low, M.B.B.S. (Hons.), F.R.A.C.S.,1,3 Charmaine M. Woods, B.Sc., Ph.D.,1
Shahid Ullah, M.Sc., Ph.D.,2 and A. Simon Carney, F.R.A.C.S., M.D.1

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ABSTRACT

Background: Nasal douching is commonly performed after endoscopic sinus surgery (ESS). There is a lack of studies comparing the clinical effect of various
douching solutions after ESS. This study investigated the clinical effects of normal saline, lactated Ringers, and hypertonic saline nasal douching solutions
after ESS.
Methods: Adult patients (41.8 12.9 years) undergoing bilateral ESS for chronic rhinosinusitis at a single tertiary referral center were blindly randomized
to one of the three study solutions and reviewed on postoperative weeks 1, 3, and 6. The 20-item Sino-Nasal Outcome Test (SNOT-20) scores, visual analog
scale (VAS) symptom scores, digital video capture of the sinus cavities, and mucociliary clearance (MCC) times were performed at each visit. The mucosa
appearances were scored by a second investigator, blinded to the douching solution.
Results: Seventy-four patients were recruited. All groups showed an improvement with treatment in SNOT-20 scores and VAS scores, as well as endoscopic
evaluation of mucosa appearance over time. There was no improvement of MCC during the treatment period. Irrigation with lactated Ringers solution resulted
in better symptom scores in SNOT-20 (p 0.05) and VAS (p 0.05), compared with irrigation with normal saline or hypertonic saline solutions. Patients
receiving hypertonic saline solutions had less polypoidal mucosa at week 6.
Conclusion: Douching with lactated Ringers solution after ESS results in better improvement in sinonasal symptoms, compared with normal saline or
hypertonic saline solutions.
(Am J Rhinol Allergy 28, 225231, 2014; doi: 10.2500/ajra.2014.28.4031)

hronic rhinosinusitis (CRS) is a common disease that affects


515% of the population.1 CRS significantly impacts the health
and quality of life of the affected individual.1,2 There is good evidence
to show that treatment with intranasal steroids, nasal douching, and
oral antibiotics result in great improvement of symptoms and quality
of life for these patients.2 For patients who fail medical treatment,
endoscopic sinus surgery (ESS) has been shown to be beneficial in
treating the symptoms for these patients.2,3
ESS improves the drainage of the sinuses as well as delivery of
topical medications to the sinuses.4 Nasal douching after surgery
remains one of the most important postoperative management strategies after ESS.2,5 Multiple studies have confirmed the benefit of
high-volume, low-pressure douching (squeeze bottle and NETI-pot;
NeilMed Pharmaceuticals Inc, Santa Rosa, CA) over other methods of
delivery.4,6 Nasal douching post-ESS has been reported to promote
wound healing and reduce nasal discharge and edema within the
tissue.7
Currently, there are a variety of formulations of nasal douches
on the market. Various studies have examined the efficacies of
various douching solutions for the treatment of CRS in the preoperative settings.812 There is a lack of evidence in the literature that
compares the efficacy of various salt-based solutions in the postoperative settings. The aim of this study is to investigate the
clinical effects of three commonly available douching solutions in

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From 1Flinders Ear, Nose. And Throat, Department of Surgery, Flinders Medical
Center and Flinders University, Bedford Park, South Australia, Australia, 2Flinders
Center for Epidemiology and Biostatistics, School of Medicine, Flinders University,
Bedford Park, South Australia, Australia, and 3Department of Otolaryngology, Royal
Prince Alfred Hospital, Camperdown, New South Wales, Australia
Presented at the annual scientific meeting of the Australian Society of Otolaryngology
Head and Neck Surgeons, Adelaide, South Australia, Australia, April 3, 2012
The authors have no conflicts of interest to declare pertaining to this article
Address correspondence to A. Simon Carney, F.R.A.C.S., M.D., Flinders ENT,
Flinders Medical Center, Bedford Park, SA 5042, Australia
E-mail address: simoncarney@me.com
Copyright 2014, OceanSide Publications, Inc., U.S.A.

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the setting of post-ESS: normal saline (0.9%), lactated Ringers, and


hypertonic saline (2.7%).

METHODS
The Southern Adelaide Clinical Human Research Ethics Committee approved this study and informed consent was obtained
from all patients. Seventy-four patients were recruited from the
public waiting list from a single tertiary referral hospital, Flinders
Medical Center during 20082011. Exclusion criteria were applied
to exclude noninflammatory etiologies (Table 1). All of the ESSs
were primary procedures performed by or performed under the
direct supervision of the senior author (A.S.C.). All patients had
bilateral ESS, involving drainage of the maxillary (conservative
mucosal sparing antrostomy), anterior, and posterior ethmoid sinuses with full preservation of the middle turbinate. Frontal and
sphenoid sinuses were drained only where clinically appropriate.
Standard mucosal sparing ESS techniques with the assistance of a
microdebrider were used in all cases.
Patients were randomly assigned to a blinded douching solution
through the Pharmacy Department at Flinders Medical Center. A
set of 80 envelopes with the name of three solutions were delivered
to the Pharmacy Department and randomly arranged. The envelopes were opened consecutively and douching solutions were
dispensed to the patients. The postoperative care of the patients
were standardized across the entire cohort. The patients were
advised to irrigate their sinuses three times a day for 6-weeks after
surgery. Blank sachets and douching bottles were provided to the
patient on the day of surgery. Patients were given standard advice
on bottle cleaning to avoid microbial contamination. No oral antibiotics or oral steroids were given to the patients. Patients were
started on intranasal steroid from between weeks 2 and 3. Routine
postoperative nasal toilet was performed at each postoperative
follow-up.
Lund-Mackay scores,13 20-item Sino-Nasal Outcome Test (SNOT20) scores,14 visual analog scale (VAS) scores,2,3 and mucociliary

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Under the age of 18 yr


Known head and neck malignancies or a history of previous
radiotherapy to the head and neck
Known MCC disorders
Systemic granulomatous disease
Unilateral ESS or ESS less than uncinectomies/middle meatal
antrostomy/anterior ethmoidectomies
Radical endoscopic frontal sinus surgery or modified Lothrop
procedures
ESS for conditions other than CRS
Revision ESS

All analyses were performed using STATA statistical software,


Version 12.0 (StataCorp 2011; StataCorp, College Station, TX)19 and R
version 2.14.2 (R Development Core Team, 2011). To determine if
irrigation solution formulation had an effect on the outcome measures
(observed data), data were analyzed by ANOVA with Bonferroni
adjustments for multiple comparisons at each time point. A value of
p 0.05 was considered significant.
A multilevel mixed effect linear regression analysis was applied
in STATA using the xtmixed command to fit linear mixed models of
VAS and SNOT-20 scores. The baseline information was normalized for insertion into the linear mixed model. Statistical modeling
was used to predict significant differences over time and between
the three treatment groups (normal saline, lactated Ringers, and
hypertonic saline).

CRS chronic rhinosinusitis; ESS endoscopic sinus surgery; MCC


mucociliary clearance.

RESULTS

Table 1 Exclusion criteria


Study Exclusion Criteria

clearance (MCC) assessment15,16 were obtained preoperatively.


Lund-Mackay scores were assessed from the preoperative computed tomography scans of the paranasal sinuses. SNOT-20 scores
were used to assess quality of life due to CRS. VAS scores were
used to assess severity of symptoms, mainly symptoms of nasal
blockage or congestion, headache, facial pain, alteration in sense of
smell, and nasal discharge. Assessment of the MCC by saccharine
clearance was performed by placing one-quarter of a saccharine
tablet on the anteriormedial aspect of the inferior turbinate. Patients were asked to remain upright, without sniffing, blowing of
the nose, or excessive swallowing. Time from placement of the
saccharine to the first taste of sweetness was recorded.
Patients were reviewed in the postoperative clinic at weeks 1, 3, and
6. The SNOT-20, VAS scores, and MCC were reassessed before application of any topical local anesthetic. The assessor and the patient
remained blinded to the douching solution. Digital video images of
the sinus cavities were captured and scored at a later date at the
conclusion of the study. Videos were scored as to the presence of
crusting and the appearance of the sinus mucosa, as previously
described.17

Power Calculations

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Based on a pilot study, power analysis indicated that 20 patients


would be required in each arm of the study to reach at least 80%
power at 5% level of significance. Power calculation was based on
a clinically relevant change for VAS score (2 points) and SNOT-20
(5 points). We assumed that the mean scores would be linear, with
possibly different slopes/intercepts for the normal saline, lactated
Ringers, and hypertonic saline groups. Data were simulated based
on change scores and SD with the mvrnorm function from the
MASS package in R (R Development Core Team).18 The ANOVA
repeated measures and F test were applied to the simulated data to
see whether or not the clinically relevant changes were rejected.
The final number was generated from 500 simulated data, resulting
in an estimate of the power (the proportion of times that the test
rejected) at 5% level of significance was 80% for the total of 60
patients, 20 in each group.

Statistical Analysis
Data are tabulated using mean (SD). The magnitude of the
change in outcome measures (SNOT-20 and VAS) was determined
using the following calculation for each individual: change
follow-up measurement baseline measurement, with group data
represented graphically as mean SEM. A negative change indicates improvement of symptoms/scores and a positive score indicates worsening of symptoms/scores.

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Of the 74 patients, 25 were randomized to the normal saline arm, 26


to lactated Ringers arm, and 23 to the hypertonic saline arm. Final
analysis was conducted on 22 normal saline, 20 lactated Ringers, and
21 hypertonic salinetreated patients, because some patients withdrew or did not attend follow-up appointments. Of these patients,
51% were diagnosed as CRS without polyps and 49% with nasal
polyps. The mean age, sex distribution, mean Lund MacKay score,
mean MCC time, mean SNOT-20 score, and mean VAS score were not
significantly different between the groups (p 0.05; Table 2) at
baseline, confirming comparable groups of patients between the three
study arms.

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VAS Score

Improvement in VAS scores were observed in the lactated Ringers group at week 1 and in all groups at weeks 3 and 6 compared
with baseline (Fig. 1). The greatest symptomatic improvement was
noted among patients within the lactated Ringers group with a
mean improvement of 6.7 2.8 points at week 1, 17.5 2.7 points
at week 3, and 28.2 3.0 points at week 6, compared with maximal
improvement at 6 weeks of 13.8 3.9 and 17.4 3.4 for normal
saline and hypertonic saline respectively.

Sinonasal Outcome Test


The observed SNOT-20 scores improved after ESS for all treatment groups (Fig. 2). However, normal saline and hypertonic
saline treatment groups showed minimal improvement at 1 week
follow-up after surgery, whereas the lactated Ringers group displayed a mean improvement of 14.7 3.7 points. At 3 weeks
follow-up all groups showed modest improvements of 1625
points from baseline levels. At 6 weeks follow-up the improvement
of SNOT-20 scores for each group was maintained, but the lactated
Ringers group showed the greatest improvement of 31.0 3.6
points, compared with 19.1 4.8 and 20.3 4.2 for normal saline
and hypertonic saline, respectively.

Mucociliary Clearance
Baseline MCC times were comparable between treatment
groups. There was no change in trend of MCC over time for each
treatment group (Fig. 3). Responses at each time point were variable, highlighting the difficulties and subjectivity of saccharine
clearance.

Statistical Modeling and Predictions of SNOT-20


and VAS Scores after Nasal Irrigation
The observed SNOT-20 and VAS data were entered into a multilevel mixed effects linear regression model to predict differences
between treatment groups over time. This model predicted significant

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Table 2 Baseline characteristics for each treatment group


Normal Saline

Lactated Ringers

Hypertonic Saline

p Value

22 (9:13)
41.5 (11.7)
56.0
10.1 (5.6)
36.1 (19.9)
31.2 (13.5)

20 (9:11)
43.6 (12.3)
53.9
10.9 (6.4)
37.8 (19.7)
34.4 (10.9)

21 (13:8)
40.4 (14.8)
60.9
11.2 (5.1)
35.6 (19.9)
31.8 (13.7)

0.68
0.88
0.83
0.93
0.68

n (CRSwNP/CRSsNP)
Age, yr, mean (SD)
Male (%)
Lund-MacKay score, mean (SD)
SNOT mean (SD)
VAS mean (SD)

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The p values are based on one-way ANOVA.


CRSwNP chronic rhinosinusitis with nasal polyp; CRSsNP chronic rhinosinusitis without nasal polyp; SNOT Sino-Nasal Outcome Test; VAS
visual analog scale.

Figure 1. Change in observed visual analog scale (VAS)


scores after treatment with normal saline, lactated Ringers,
and hypertonic saline irrigations 1, 3, and 6 weeks after
surgery. Data are presented as change from baseline (mean
SEM). All formulations showed an improvement in SNOT-20
scores over the 6-week period, with lactated Ringers showing
the most improvement.

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Figure 2. Change in observed 20-item Sino-Nasal Outcome


Test (SNOT-20) scores after treatment with normal saline,
lactated Ringers, and hypertonic saline irrigation 1, 3, and 6
weeks after surgery. Data are presented as change from baseline (mean SEM). All formulations showed an improvement in SNOT-20 scores over the 6-week period, with lactated Ringers showing the most improvement.

Figure 3. Mucociliary clearance (MCC) times (mean SEM)


after treatment with normal saline, lactated Ringers, and hypertonic saline irrigation at baseline (before surgery) and 1, 3, and 6
weeks after surgery. Irrigation formulation had minimal effect on
MCC after endoscopic sinus surgery (ESS).

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Table 3 A multilevel mixed effects linear regression model predicting time effects for SNOT-20 and VAS scores after irrigation with
lactated Ringers, hypertonic saline, or normal saline over 1, 3, 6 wk after ESS
Measures

SNOT-20

VAS

Time

Week
Week
Week
Week
Week
Week

Predicted Marginal Mean Change (95% CI)

1
3
6
1
3
6

Normal Saline

Lactated Ringers

Hypertonic Saline

3.15 (10.21 to 3.91)


18.41* (25.59 to 11.23)
20.22* (27.17 to 13.27)
2.86 (3.01 to 8.73)
11.94* (17.91 to 5.97)
14.07* (19.85 to 8.29)

14.67* (22.06 to 7.27)


24.73* (32.26 to 17.21)
28.71* (36.53 to 20.88)
6.72* (12.88 to 0.57)
17.39* (23.65 to 11.13)
26.70* (33.21 to 20.19)

4.24 (11.06 to 2.61)


17.04* (23.98 to 10.09)
20.83* (27.78 to 13.88)
0.81 (6.51 to 4.89)
12.67* (18.45 to 6.88)
17.36* (23.14 to 11.57)

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Marginal mean change (95% CI); changes in weeks 1, 3, and 6 from baseline for each group after adjustment baseline measures.
*p 0.05 compared with baseline measurement.
ESS endoscopic sinus surgery; SNOT-20 20-item Sino-Nasal Outcome Test; VAS visual analog scale.

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Table 4 A multilevel mixed effects linear regression model predicting group effects for SNOT-20 and VAS scores after irrigation with
lactated Ringers, hypertonic saline or normal saline over 1, 3, 6 wk after ESS
Measures

SNOT-20

VAS

Time

Week
Week
Week
Week
Week
Week

Predicted Marginal Mean Difference (95% CI)

1
3
6
1
3
6

Lactated Ringers vs
Normal Saline

Lactated Ringers vs
Hypertonic Saline

10.61* (19.38 to 1.84)


5.42 (14.39 to 3.56)
7.58# (16.64 to 1.48)
7.45* (14.55 to 0.35)
3.13 (10.59 to 3.94)
10.50* (17.85 to 3.15)

1.33 (9.77 to 7.10)


1.13 (7.49 to 9.75)
0.86 (9.29 to 7.57)
4.26 (11.07 to 2.56)
1.32 (8.29 to 5.65)
3.87 (10.68 to 2.93)

Marginal mean difference (95% CI); difference comparing lactated Ringers to normal saline or hypertonic saline irrigation, after adjustment for baseline
measures.
*p 0.05; #p 0.10.
ESS endoscopic sinus surgery; SNOT-20 20-item Sino-Nasal Outcome Test; VAS visual analog scale.

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Table 5 Mean (SD) VAS scores among normal saline, lactated Ringers, and hypertonic saline at week 6 across all six VAS domains

Nasal blockage and congestion


Headache
Facial pain
Smell
Nasal discharge
Combined nasal symptoms

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Normal Saline Mean


(SD)

Lactated Ringers Mean


(SD)

Hypertonic Saline Mean


(SD)

2.8 (2.6)
2.8 (2.9)
2.4 (2.7)
2.9 (2.6)
2.8 (3.1)
2.8 (2.5)

1.7 (1.4)*#
1.7 (2.1)*#
0.4 (0.7)*#
2.1 (2.6)
1.2 (1.5)*#
2.1 (1.6)*#

2.4 (3.6)
2.5 (3.1)
1.8 (2.3)
2.1 (2.9)
1.9 (2.2)
2.5 (2.3)

*p 0.05 lactated Ringers compared with standard treatment with normal saline; #p 0.05 0.08 lactated Ringers compared with treatment with hypertonic
saline.
VAS visual analog scale.

reductions in SNOT-20 scores for lactated Ringers at week 1 (p


0.05) and all treatment groups at week 3 (p 0.05) and week 6 (p
0.05) compared with baseline (Table 3). The reduction in SNOT-20
score was more pronounced for the lactated Ringers group than
the normal saline or hypertonic saline groups. A significant improvement is predicted for the lactated Ringers group at week 1
compared with irrigation with normal saline (mean difference of
10.61 points; p 0.05) and approaching significance at 6 weeks
(mean difference of 7.58 points; p 0.10; Table 4).
The model predicted significant reductions in VAS scores for
lactated Ringers at week 1 (p 0.05) and all treatment groups at
week 3 (p 0.05) and week 6 (p 0.05) compared with baseline
(Table 3). The reduction in VAS scores were more pronounced for
the lactated Ringers group than the normal saline and hypertonic
saline groups. A significant improvement is predicted for the

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lactated Ringers group at week 1 (mean difference of 7.45 points;


p 0.05) and week 6 (mean difference of 10.50 points; p 0.05)
compared with the standard treatment of irrigation with normal
saline (Table 4).
At 6 weeks, patients in the lactated Ringers group reported significantly better VAS symptom severity across most domains of sinonasal symptoms (Table 5), mainly nasal congestion/blockage (p 0.05),
headache (p 0.05), facial pain (p 0.05), and nasal discharge (p
0.05) compared with the normal saline treatment group. A similar
result was observed for the same VAS domains when the lactated
Ringers group was compared with the hypertonic saline group (approaching significance with p 0.050.08).
No time or group effect was evident for MCC from a multilevel
mixed effects linear regression model; therefore, these data were not
shown in Tables 3 and 4.

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Table 6 Endoscopic scores on the amount of crusting in normal saline, lactated Ringers, and hypertonic saline treatment groups 1, 3,
and 6 wk after surgery

Week 1

Week 3

Week 6

Endoscopic Crustings

Normal Saline (%)

Lactated Ringers (%)

Hypertonic Saline (%)

No crust/few crusts
50% crusts
50% crusts
No crust/few crusts
50% crusts
50% crusts
No crust/few crusts
50% crusts
50% crusts

15.0
25.0
60.0
41.2
35.3
23.5
78.9
21.1
0.0

15.0
30.0
55.0
31.6
63.2
5.3
56.3
37.5
6.3

19.0
19.0
61.9
52.6
31.6
15.8
84.2
10.5
5.3

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Table 7 Endoscopic appearance of mucosa in normal saline, lactated Ringers, and hypertonic saline treatment groups 1, 3, and 6 wk
after surgery

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Endoscopic Appearance of Mucosa

Normal Saline (%)

Lactated Ringers (%)

Hypertonic Saline (%)

Normal
Edema/cobblestone
Polypoid
Gross polypoid
Normal
Edema/cobblestone
Polypoid
Gross polypoid
Normal
Edema/cobblestone
Polypoid
Gross polypoid

0
5.0
95.0
0
0
11.8
88.2
0
0
31.6
68.4
0

0
10.0
90.0
0
0
10.0
90.0
0
0
26.7
73.3
0

0
4.8
95.2
0
0
52.6
47.4
0
0
72.2
27.8
0

Week 1

Week 3

Week 6

Endoscopic Scores

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In the early phase of recovery (week 1), 59% patients were found to
have a large amount of crusting (50%) within the sinonasal mucosa,
which improved (50% crusting) or resolved (no crusting) in all but
two patients by week 6 (Table 6). This improvement was consistent
across all treatment groups.
None of the patients showed gross polypoid disease during the
follow-up period. In addition, none of the patients showed a
completely normal appearance of the nasal mucosa at week 6. The
amount of polypoidal mucosa improved slowly during the treatment period for normal saline and lactated Ringers groups, but
70% of these patients still displayed polypoidal mucosa at 6 weeks
follow-up. The recovery from polypoidal to cobblestone mucosa
was better among the patients irrigating with hypertonic saline
solution, with 53% cobblestone at 3 weeks and 72% at 6 weeks
follow-up (Table 7).

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DISCUSSION

This prospective, double-blind, randomized controlled trial was


performed to compare the clinical effectiveness of normal saline,
lactated Ringers, and hypertonic nasal douching solution after
primary ESS. Various tools including SNOT-20, VAS, MCC, and
endoscopic scorings were used to evaluate the progress of patients
to quantify the effect on quality of life, symptom severity, mucociliary function, and mucosal recovery postsurgery.
Nasal douching is a mainstay treatment for patients suffering
from CRS. It is thought to improve mucociliary function, decrease
mucosal edema, and dilute inflammatory mediators, as well as
mechanically clearing inspissated mucous.7 Studies have also
shown that douching postfunctional ESS surgery improves symptoms and appearance of mucosa within the sinus cavities.20,21 The

efficiency of various delivery methods of nasal douching solutions


has been studied previously.6,22,23 High-volume, low-pressure delivery systems offer the most efficient delivery of douching solution into the sinuses. Optimal penetration of the solution into
various sinuses is also dependent on the position of the patient
while douching. Most effective penetration, especially into the
frontal sinus is noted with patients head at 90 to the vertical
axis.24 In this study, patients were advised to perform douching
with a squeeze bottle (provided) to deliver low-pressure and highvolume solutions. They were also advised to perform douching in
the head down position. As such, we believe the methodology used
in this study is in keeping with current best practice for postoperative sinus irrigation and the results translatable into individuals
general clinical practice.
This study confirmed that ESS with postoperative irrigation
provides for an improvement in quality of life and symptom
control as measured by SNOT-20 and VAS scores. The SNOT-20 is
a validated tool to assess the health status and quality of life
resulting from CRS.14 The VAS scores have been widely used by
many authors to quantify the severity of symptoms secondary to
CRS.2,3 Our study indicates that douching with lactated Ringers
solution resulted in better (as well as faster) resolution of symptoms after ESS when compared with saline or hypertonic saline
solutions over the first 6 weeks after surgery. Douching with
lactated Ringers solution also resulted in better resolution of the
severity of symptoms from CRS, compared with the other solutions, in particular, for symptoms of nasal blockage or congestion,
headache, facial pain, and nasal discharge.
Lactated Ringers solution is a physiological solution, composed of
sodium lactate, NaCl, KCl, and CaCl2.25 Compared with the isotonic
and hypertonic saline, lactated Ringers solution may result in a less
noxious stimuli within the nasal mucosa, resulting in better symptom

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229

scores. Hypertonic solutions have been shown to stimulate the release


of substance P within the airway.26 Substance P is also known to
stimulate pain fibers.27 We postulate that this mechanism could result
in the nasal discomfort often reported during douching with hypertonic saline solution and this may be reflected as worse symptom
scores. Previous studies with lactated Ringers solution have showed
improvement of mucociliary function both in in vivo25 and in vitro28
environments. These results support our findings in this study that
lactated Ringers solution may be better tolerated within the nasal
mucosa as a douching solution. Although the differences between the
three solutions tested were small, the statistically significant findings
are also likely to be clinically significant owing to the better VAS
symptom scores and SNOT-20 results. In many countries, lactated
Ringers may be more expensive for the patient than the two saline
solutions tested. There may need to be decisions made on a cost
benefit analysis if surgeons were planning to change their practice. In
Australia, we recommend the use of single-use sterile sachets rather
than large-volume solutions made by the patients. As such, switching
to lactated Ringers has no cost penalty to the patients in our practice.
CRS results in a reduced quality of life1,2 and ESS is known to
improve the symptom severity from CRS.2,3 Nasal irrigation after
ESS has become standard practice in many areas. This study has
shown that the rate and the magnitude of improvement in the
symptom severity are enhanced with the use of lactated Ringers
solution, over normal or hypertonic saline. Douching post-ESS has
also been shown to improve the appearance of the nasal mucosa
post-ESS.21 This effect is also seen in our study, where the amount
of crusting and polypoidal appearance of the mucosa improved
over time with treatment. There was no difference between the rate
of crust resolution within the sinus cavity between the three solutions tested. However, hypertonic saline solution resulted in the
quicker resolution of polypoidal mucosa. The mechanism for this is
unknown. However, the improved appearance of the nasal mucosa
did not result in better symptom scores among the patients receiving hypertonic saline. This finding is consistent with other studies
where nasal irrigation with hypertonic solution resulted in improved radiological appearances of the sinuses among pediatric
patients with CRS, but not the symptom scores, compared with
normal saline solution.29
Our study showed a wide variability of MCC response time among
the patients as measured by the saccharine clearance test. It also
showed a trend of improved MCC over the observation period. The
improvement is slow and modest, with no difference among the three
groups. This could reflect the slow nature of recovery of the nasal
mucosa after the insult from surgery, as previously noted.30 This is
also supported by the observations in this current study where the
nasal mucosa remains cobblestone at 6 weeks postsurgery, with none
returning to normal, despite good compliance.
One limitation of this study is that it included patients with both
CRS without polyps and CRS with nasal polyps. Subgroup analysis
between these two groups within the three experimental arms
were not possible because the numbers were too small to provide
sensible statistical analysis. Well-powered larger studies looking at
patients either with or without polyps would be logistically challenging but would establish whether our findings might be limited
to, or even more significant, in one of the CRS subgroups.

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ACKNOWLEDGMENTS
The authors acknowledge Penny Harris and Caroline Wuller for
their assistance with data entry. Blank irrigation bottles and sachets for this study were generously provided by NeilMed and
ENT Technologies.

REFERENCES
1.
2.

3.

4.

5.
6.
7.

8.

O
N

T
9.

10.

11.

12.

13.
14.

15.

16.

17.
18.

19.
20.

CONCLUSIONS

21.

Nasal irrigation post-ESS is effective in symptom resolution and


normalization of mucosa appearances. Symptomatic improvement
was significantly more effective with lactated Ringers solution compared with normal saline and hypertonic saline solutions over the
first 6 postoperative weeks.

22.

230

Y
P

Brown CL, and Graham SM. Nasal irrigations: Good or bad? Curr
Opin Otolaryngol Head Neck Surg 12:913, 2004.
Fokkens WJ, Lund VJ, Mullol J, et al. EPOS 2012: European position
paper on rhinosinusitis and nasal polyps 2012. A summary of Otorhinolaryngologists. Rhinology 50:112, 2012.
Lund VJ, Holmstrom M, and Scadding GK. Functional endoscopic
sinus surgery in the management of chronic rhinosinusitis. An objective assessment. J Laryngol Otol 105:832835, 1991.
Harvey RJ, Goddard JC, Wise SK, and Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation.
Otolaryngol Head Neck Surg 139:137142, 2008.
Fernandes SV. Postoperative care in functional endoscopic sinus
surgery? Laryngoscope 109:945948, 1999.
Wormald PJ, Cain T, Oates L, et al. A comparative study of three
methods of nasal irrigation. Laryngoscope 114:22242227, 2004.
Tomooka LT, Murphy C, and Davidson TM. Clinical study and
literature review of nasal irrigation. Laryngoscope 110:11891193,
2000.
Harvey R, Hannan SA, Badia L, and Scadding G. Nasal saline irrigations for the symptoms of chronic rhinosinusitis. Cochrane Database Syst Rev 3:CD006394, 2007.
Rabago D, Pasic T, Zgierska A, et al. The efficacy of hypertonic saline
nasal irrigation for chronic sinonasal symptoms. Otolaryngol Head
Neck Surg 133:38, 2005.
Rabago D, Barrett B, Marchand L, et al. Qualitative aspects of nasal
irrigation use by patients with chronic sinus disease in a multimethod
study. Ann Fam Med 4:295301, 2006.
Weissman JD, Fernandez F, and Hwang PH. Xylitol nasal irrigation
in the management of chronic rhinosinusitis: A pilot study. Laryngoscope 121:24682472, 2011.
Garavello W, Romagnoli M, Sordo L, et al. Hypersaline nasal irrigation in children with symptomatic seasonal allergic rhinitis: A randomized study. Pediatr Allergy Immunol 14:140143, 2003.
Lund VJ, and Mackay IS. Staging in rhinosinusitis. Rhinology 31:183
184, 1993.
Piccirillo JF, Merritt MG Jr, and Richards ML. Psychometric and
clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT20). Otolaryngol Head Neck Surg 126:4147, 2002.
Stanley P, MacWilliam L, Greenstone M, et al. Efficacy of a saccharin
test for screening to detect abnormal mucociliary clearance. Br J Dis
Chest 78:6265, 1984.
Bachmann G, Hommel G, and Michel O. Effect of irrigation of the
nose with isotonic salt solution on adult patients with chronic
paranasal sinus disease. Eur Arch Otorhinolaryngol 257:537541,
2000.
Kupferberg SB, Bent JP III, and Kuhn FA. Prognosis for allergic
fungal sinusitis. Otolaryngol Head Neck Surg 117:3541, 1997.
R Development Core Team. R: A language and environment for
statistical computing. R. Foundation for Statistical Computing,
Vienna, Austria, http://www.R-project.org 2012.
StataCorp. Stata Statistical Software: Release 12. College Station, TX:
StataCorp LP, 2011.
Jorissen M. Postoperative care following endoscopic sinus surgery.
Rhinology 42:114120, 2004.
Freeman SRM, Sivayoham ESG, Jepson K, and de Carpentier J. A
preliminary randomised controlled trial evaluating the efficacy of
saline douching following endoscopic sinus surgery. Clin Otolaryngol 33:462465, 2008.
Olson DE, Rasgon BM, and Hilsinger RL Jr. Radiographic comparison of three methods for nasal saline irrigation. Laryngoscope 112:
13941398, 2002.

O
C

MayJune 2014, Vol. 28, No. 3

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23.

24.

25.

26.

Harvey RJ, Goddard JC, Wise SK, and Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation.
Otolaryngol Head Neck Surg 139:137142, 2008.
Singhal D, Weitzel EK, Lin E, et al. Effect of head position and
surgical dissection on sinus irrigant penetration in cadavers. Laryngoscope 120:25282531, 2010.
Unal M, Gorur K, and Ozcan C. Ringer-Lactate solution versus
isotonic saline solution on mucociliary function after nasal septal
surgery. J Laryngol Otol 115:796797, 2001.
Baraniuk JN, Ali M, Yuta A, et al. Hypertonic saline nasal provocation stimulates nociceptive nerves, substance P release, and glandular
mucous exocytosis in normal humans. Am J Respir Crit Care Med
160:655662, 1999.

27.

28.

29.

30.

Ganong W. Chapter 7: Neurotransmitters & Neuromodulators. In


Review of Medical Physiology, 24 ed. Barrett KE, Boitano S, Barman
SM and Brooks HL (Eds). McGraw Hill, Lange Medical Publisher,
New York, NY 135154, 2012.
Unal M, and Seymen H. Effect of Ringer-Lactate and isotonic saline
solutions on mucociliary clearance of tracheal epithelium: An experimental study in rats. J Laryngol Otol 116:536538, 2002.
Shoseyov D, Bibi H, Shai P, et al. Treatment with hypertonic saline
versus normal saline nasal wash of pediatric chronic sinusitis. J
Allergy Clin Immunol 101:602605, 1998.
Cowin A, McIntosh D, and Wormald PJ. Healing of wounds created in the
nasal mucosa following endoscopic sinus surgery can be affected by different nasal packing materials. Primary Intention 10:114117, 2002.
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