A Double-Blind Randomized Controlled Trial of Normal Saline, Lactated Ringer's, and Hypertonic Saline Nasal Irrigation Solution After Endoscopic Sinus Surgery
A Double-Blind Randomized Controlled Trial of Normal Saline, Lactated Ringer's, and Hypertonic Saline Nasal Irrigation Solution After Endoscopic Sinus Surgery
A Double-Blind Randomized Controlled Trial of Normal Saline, Lactated Ringer's, and Hypertonic Saline Nasal Irrigation Solution After Endoscopic Sinus Surgery
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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)
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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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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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RESULTS
Power Calculations
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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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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.
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.
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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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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
1
3
6
1
3
6
Normal Saline
Lactated Ringers
Hypertonic Saline
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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
1
3
6
1
3
6
Lactated Ringers vs
Normal Saline
Lactated Ringers vs
Hypertonic Saline
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
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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.
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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
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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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
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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.
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