Comparison of pain levels after abdominal surgery in patients receiving pregabalin and famotidine with pregabalin and diphenhydramine in the hospitals of Islamic Azad University, Tehran Medical Branch in 2022
Determining the amount of pain after abdominal surgery in patients receiving pregabalin and famotidine with pregabalin and diphenhydramine
Design
A double-blind, parallel-group, randomized clinical trial on 34 patients. Randomized by online random number table
Settings and conduct
In order to make this study double-blind, the drugs used for the patients at the beginning of the study were divided into A/B groups by the head of the surgery department so that the researcher and the participants did not know the type of drug received. Medications were prescribed two hours before surgery, along with 50 cc water according to the following instruction:
Weight less or equal to 60 kg a tablespoon of diphen hydramin syrup.
More weight or than 60 kg two tablespoons of diphen hydramin syrup.
Famotidine 75 mg with 50 cc of water.
At the time of entering the recovery room and at 6, 12, 24 hours after the operation, the pain level of the patients was measured based on the VAS scale, and if the VAS was >5, 30-50 mg of pethidine was injected intravenously. At the end of the first day, the amount of narcotics used was recorded in the questionnaire by a trained nurse.
Participants/Inclusion and exclusion criteria
Age 15-75 years old; informed and written consent; ASA 1 and 2; no use of drugs and alcohol; elective surgery
Intervention groups
Group A (receiver of pregabalin and famotidine) and B (receiver of pregabalin and diphenhydramine)
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230106057067N1
Registration date:2023-03-19, 1401/12/28
Registration timing:retrospective
Last update:2023-03-19, 1401/12/28
Update count:0
Registration date
2023-03-19, 1401/12/28
Registrant information
Name
parnian motamed chaboki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8827 9693
Email address
parnianmotamed@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
2022-06-22, 1401/04/01
Actual recruitment end date
2022-12-22, 1401/10/01
Trial completion date
2022-12-22, 1401/10/01
Scientific title
Comparison of pain levels after abdominal surgery in patients receiving pregabalin and famotidine with pregabalin and diphenhydramine in the hospitals of Islamic Azad University, Tehran Medical Branch in 2022
Public title
Comparison of pain levels after abdominal surgery in patients receiving pregabalin and famotidine with pregabalin and diphenhydramine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15-75 years old
Informed and written consent
ASA class 1 or 2
No abuse of drugs and alcohol
Elective surgery
Exclusion criteria:
Loss of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
Operation is more than 4 hours
Age
From 15 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, first, a list of all patients who were willing to participate in the research was prepared, and after matching the patients who met the inclusion criteria, we assigned a number to each patient. We considered numbers 1 to 17 as group A and 18 to 34 as group B. Then, using an online random number table, the patients were placed in two groups (A group receiving pregabalin and famotidine and B group receiving pregabalin and diphenhydramine).
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the double-blindness of this study, the drugs used for the patients were divided in A/B form by the head of the surgery department at the beginning of the study so that the researcher and the participants did not know the type of drug received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-06-15, 1401/03/25
Ethics committee reference number
IR.IAU.TMU.REC.1401.071
Health conditions studied
1
Description of health condition studied
Abdominal surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
PAIN
Timepoint
After entering recovery and 24, 12, 6 hours after the operation
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
One group received pregabalin and famotidine. The way to calculate the amount of drug and puff spray in patients was as follows: Famotidine 40 mg. Pregabalin 75 mg
Category
Treatment - Drugs
2
Description
One group received pregabalin and diphenhydramine. The way to calculate the amount of medicine and puff spray in patients was as follows: weight less than or equal to 60 kg, one spoon of diphenhydramine syrup. Weight more than 60 kg, two spoons of diphenhydramine syrup. Pregabalin 75 mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated to Tehran Islamic Azad University of Medical Sciences (Boali, Amir and Farhikht
Full name of responsible person
Mahnaz Narimani Zamanabadi
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Majid Naqipour
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parnian Motamed Chabaki
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 912 074 3989
Email
Parnianmotamed@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Narimani Zamanabadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 912 146 9581
Email
mahnaznarimani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Narimani Zamanabadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 912 146 9581
Email
mahnaznarimani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD