A clinical trial on the effects of promethazine and gabapentin as pre-medication in reducing postoperative pain in 7- to 9-year-old patients undergoing tonsillectomy
This study compares the effects of promethazine and gabapentin as premedication on postoperative pain reduction in tonsillectomy. A total of 104 patients aged from 7 to 15 years undergoing tonsillectomy who have inclusion criteria (non-addiction to and non-use of psychotropic and psychoactive drugs; no history of anxiety, neuropsychiatric, and hyperactivity disorders or chronic pain) will be incorporated upon provision of informed consent. The study is double-blind and will be performed in the second phase of clinical trial. Prior to complete anesthesia, the participants will be allocated into gabapentin or promethazine groups via simple allocation method (n = 52 per group). The gabapentin group receives 20 milligrams per kilogram along with 50 cc of water one hour before anesthesia. The promethazine group receives 0.5 cc per kilogram and up to a maximum dose of 25 milligram promethazine syrup orally one hour before anesthesia. Postoperative pain at 3, 6, 12 and 24 hours after the operation will be measured using the Medical Objective Pain Scale in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051517756N14
Registration date:2017-07-05, 1396/04/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-05, 1396/04/14
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery for Research of Birjand University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on the effects of promethazine and gabapentin as pre-medication in reducing postoperative pain in 7- to 9-year-old patients undergoing tonsillectomy
Public title
Comparing the effects of promethazine and gabapentin as premedication in reducing pain in tonsillectomy operation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: non-addiction to and non-use of psychotropic and psychoactive drugs; no history of anxiety, neuropsychiatric, and hyperactivity disorders or chronic pain; age between 7 and 15 years; patient referred by the ENT specialist, co-researcher in this project; non-use of drugs effective on heart rate and pressure; informed consent.
Exclusion criteria: Surgery length over 30 minutes; complications during or after surgery, e.g., bleeding and hypoxia
Age
From 7 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
104
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
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice-chancellery for Research, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2017-05-01, 1396/02/11
Ethics committee reference number
Ir.bums.REC.1396.32
Health conditions studied
1
Description of health condition studied
Post-operative pain
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
Pain severity
Timepoint
3, 6, 12 and 24 hours after operation
Method of measurement
Medical Objective Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1 (Gabapentin group): The gabapentin group receives 20 milligrams per kilogram along with 50 cc of water one hour before anesthesia. Postoperative pain at 3, 6, 12 and 24 hours after the operation will be measured using the Medical Objective Pain Scale.
Category
Treatment - Drugs
2
Description
Intervention Group 2 (The promethazine group): The group receives 0.5 cc per kilogram and up to a maximum dose of 25 milligram promethazine syrup orally one hour before anesthesia. Postoperative pain at 3, 6, 12 and 24 hours after the operation will be measured using the Medical Objective Pain Scale.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Masoud Madihi
Street address
Ghafari Street,
City
Birjand,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellery for Research, Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Vice chancellor for research, Birjand University of Medical Sciences, Ayatollah Ghafari Street,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery for Research, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Masoud Madihi
Position
Medical Student
Other areas of specialty/work
Street address
Ghaffari St., Birjand University of Medical Sciences,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
masoud.madihi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mahmoud Ganjifard
Position
Associate Professor
Other areas of specialty/work
Street address
Vali-e Asr Hospital, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
ganji50@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
hadirooz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)