The goal of study was compairing effect of honey and diphenhydramine on post tonsillectomy pain. This study did double blind clinical trial. 120 children 5-12 who candidated for tonsillectomy studied. main exclusion criteria were dissatisfaction of cooperation, sensitivity to honey, inability to count number 1-5, lack of swalloing reflex. Patients divided randomly to four equal groups, after tonsillectomy first group received pure honey 5cc a one hour depended on wished child, second group received 50% honey 5cc a one hour depended on wished child, third group received diphenhydramine 1mg/kg every six hour, fourth group follow up without intervention. All groups received acetaminophen 10mg/kg every six hour. The intensity of pain was evaluated in 0,3,6,12,24 hours after tonsillectomy by Oucher questioner
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207086252N3
Registration date:2012-08-31, 1391/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-31, 1391/06/10
Registrant information
Name
Soroush Amani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1226 4834
Email address
samani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2009-03-20, 1387/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of honey and Diphenhydramine for control post tonsillectomy pain in children
Public title
effect of honey on pain after tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: children between 5-12 years undergoing tonsillectomy
exclusion criteria: children between 5-12 undergoing tonsillectomy who were dissatisfacted of cooperation; children between 5-12 undergoing tonsillectomy who had sensitivity to honey; children between 5-12 undergoing tonsillectomy who could not count numbers 1-5, and lack of swalloing reflex
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Science
Street address
Ayatolah Kashani Avenue
City
Shahrekord
Postal code
8815713471
Approval date
2006-10-23, 1385/08/01
Ethics committee reference number
85-7-3
Health conditions studied
1
Description of health condition studied
Tonsillar Hypertrophy
ICD-10 code
R07.0
ICD-10 code description
Pain in Throat
Primary outcomes
1
Description
Pain
Timepoint
0-3-6-12,24 hours after tonsillectomy
Method of measurement
Oucher Questionnaire
Secondary outcomes
1
Description
Hemorrhage
Timepoint
24 hours after surgery
Method of measurement
Visual
2
Description
Nausea and Vomiting
Timepoint
24 hours after surgery
Method of measurement
Visual
Intervention groups
1
Description
Third group was treated with 1mg/kg diphenhydramine every 6 hours, after surgery
Category
Treatment - Drugs
2
Description
First group after tonsillectomy and beginning of eating took 5cc pure honey every an hour
Category
Treatment - Drugs
3
Description
Second group after tonsillectomy and beginning of eating took 5cc, 50% honey every an hour
Category
Treatment - Drugs
4
Description
Forth group was observed without any intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatolah kashani Hospital
Full name of responsible person
Soroush Amani MD
Street address
Ayatolah kashani Hospital,Shariati Avenue
City
Sharekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmood Mobasheri
Street address
Shahrekord University of Medical Sciences, Kashani Avenue
City
Shahrekord
Grant name
بودجه تحقیقات دانشگاه
Grant code / Reference number
410
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist/Assosiate Professor of University
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Avenue
City
Shahrekord
Postal code
8815713471
Phone
+98 38133300615
Fax
+98 38 1334 3004
Email
info@skums.ac.ir soamani2008@yahoo.com
Web page address
www.SKUMS.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Avenue
City
Shahrekord
Postal code
8815713471
Phone
+98 38133300615
Fax
+98 38 1334 3004
Email
info@skums.ac.ir soamani2008@yahoo.com
Web page address
www.SKUMS.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist, Associate Professor of Shahrekord University of Medical Sciences
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Avenue
City
Shahrekord
Postal code
8815713471
Phone
+98 38133300615
Fax
+98 38 1334 3004
Email
info@skums.ac.ir soamani2008@yahoo.com
Web page address
www.SKUMS.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)