Study of the efficacy of aloe vera mouthwash on reduction of post Adenotonsillectomy pain in 5-12 years old children referred to Behesht Hospital of Hamedan in 2019 : three blind randomized clinical trial
The efficacy of aloe vera mouthwash on the reduction of post-Adenotonsillectomy pain in 5-12 years old children
Design
Interventional and Practical Clinical Trial, Triple-blind, quadruple block randomization, 110 samples in each, intervention and control groups.
Settings and conduct
Patients who were candidates for surgery who had been referred to the ENT clinic of Hamadan Besat hospital for one year after the approval of this plan, were included in the study if they were eligible for inclusion and signature of consent. The surgery was performed at 8 to 12 am in Besat hospital. In the surgery room, before the start and after the surgery, surgeon washed the surgical site with the solution for one minute. The following days, patient washed their mouth with the solution 3 times daily and data were noted daily by the researcher using phone call. According to the method of intervention and coding, the patients, researcher, and statistical analyzer were blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Children aged 5 to 12 years old; both sexes;candidates for adenotonsillectomy.
Exclusion criteria:Sensitivity to aloe vera, use of cautery in surgery, any systemic illness,No understanding of visual scale by child; No consent of the child's parents
Intervention groups
Intervention group:The surgical site was washed.Then 10 cc of Aloe vera mouth wash was applied 1 minute before the surgery and the same amount right after surgery.The mouth wash was used 5 ccs 3 times a day for 5 days.
Control group:The surgical site was washed.Then 10 cc of normal saline mouth wash was applied 1 minute before the surgery and the same amount right after surgery.The mouth wash was used 5 ccs 3 times a day for 5 days.
Main outcome variables
Scale of sore throat in the Visual Analog Scale (VAS) Questionnaire in the first 5 days after adenotonsillectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130713013976N7
Registration date:2019-09-08, 1398/06/17
Registration timing:retrospective
Last update:2019-09-08, 1398/06/17
Update count:0
Registration date
2019-09-08, 1398/06/17
Registrant information
Name
Javaneh Jahanshahi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0020
Email address
j.jahanshahi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-06-20, 1398/03/30
Trial completion date
2019-06-20, 1398/03/30
Scientific title
Study of the efficacy of aloe vera mouthwash on reduction of post Adenotonsillectomy pain in 5-12 years old children referred to Behesht Hospital of Hamedan in 2019 : three blind randomized clinical trial
Public title
Effect of Aloe vera in Adenotonsillectomy pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing Adenotonsillectomyک
Age 4 to 12 yearsک
Both sexes
Exclusion criteria:
Sensitivity to Aloe vera
Any known systemic disease, such as congenital anomalies, bleeding disorders, type 1 diabetes, kidney disease, colds, and fever
Using cautery during surgery
No understanding the pain assessment tool (VAS) by the child;
No parental consent
Age
From 5 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
220
Actual sample size reached:
220
Randomization (investigator's opinion)
Randomized
Randomization description
This activity was performed by a pharmacist colleague.
For this purpose, quadratic block randomization was used. Therefore, four sheets of paper were prepared and written on two letters A (for Aloe vera group) and two other letters N (for normal saline). The sheets were mixed together and placed in a drawer. One of the sheets was randomly drawn out and assigned to one of two groups (aloe vera or normal saline) whether the paper was assigned to as A or N and thus each group of normal saline and aloe vera bottles was randomly numbered from one to one hundred and twenty. It should be noted that the extruded sheets were not returned to the drawer until all four sheets were removed, and after all the four sheets were randomly removed, all the sheets were returned to the drawer again and the above operation was carried out for another four bottles until one hundred. And ten cases from each group continued.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the shape of both bottles (aloe vera and placebo) was identical and was coded by a randomized four-block method. Bottle distributors (researchers), patients and the person performing the statistical analysis were not aware of the nature of the substance in the bottle, and after completing the data analysis and identifying the results, the drug code was decoded and the affect of each drug was identified and recorded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Science
Street address
Ethics Committee of Hamadan University of Medical Science, Khaje Rashid Blv., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
1234567890
Approval date
2015-08-16, 1394/05/25
Ethics committee reference number
IR.UMSHA.REC.1394.276
Health conditions studied
1
Description of health condition studied
Adenotonsillar hypertrophy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sore throat
Timepoint
Measurement of sore throat in the first 5 days after Adenotonsillectomy
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
The frequency of use of prescribed acetaminophen intake
Timepoint
In the first 5 days after Adenotonsillectomy
Method of measurement
Questionnaire
2
Description
Ear pain (autoelastic)
Timepoint
In the first 5 days after Adenotonsillectomy
Method of measurement
Questionnaire
3
Description
Normal diet tolerance
Timepoint
In the first 5 days after Adenotonsillectomy
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: The surgical site was washed. Then 10 cc of Aloe vera mouth wash was applied 1 minute before the surgery and the same amount right after surgery. The mouth wash was used 5 cc 3 times a day for 5 days.
Category
Treatment - Drugs
2
Description
Control group: The surgical site was washed. Then 10 cc of normal saline mouth wash was applied 1 minute before the surgery and the same amount right after surgery. The mouth wash was used 5 cc 3 times a day for 5 days.