Comparison of the efficiency and side effects of morphine and diclofenac suppositories with intramuscular pethedine in controlling post operative pain in appendectomy and inguinal hernia
In this study, the efficacy and complications of two suppositories including morphine and diclofenac were assessed versus pethidine as a safe method for post operative analgesia in appendectomy&surgery of inguinal hernia. The study population included patients diagnosed with acute appendicitis and Inguinal Hernia undergoing surgery at the Fatemi Hospital (and in the age group ranged from 18-70). Pregnant patients and patients with neurological or psychiatric disorders and other systemic diseases were not included in the study. The sample size of 75 people who were randomly assigned into 3 groups of 25 patients were studied in double blind form. The first group received 10 mg of suppository morphine during the 2th, 6th, 12th and 24th hours after surgery, and the second group received suppository diclofenac during the same times. In the third group, if the patient had postoperative pain, 50 mg intramusclar pethidine (PRN) was used to control pain provided that the patient had a score above 4.To measure patient pain score based on VAS criteria , graded ruler of 0 to 10 (according to the variables table) was used,To measure patient vomiting& nausea score N&V scales was Used, to score the patients sedation ramsy sedation score was used. And were enclosed in the forms prepared for this aim.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071134841N2
Registration date:2017-09-02, 1396/06/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Ahmad Ghazi
Name of organization / entity
Ardabil University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 3324 8888
Email address
a.gazi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy Research Ardabil University of Medical Sciences
Expected recruitment start date
2013-03-27, 1392/01/07
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficiency and side effects of morphine and diclofenac suppositories with intramuscular pethedine in controlling post operative pain in appendectomy and inguinal hernia
Public title
Comparison of the efficiency and side effects of morphine and diclofenac suppositories with intramuscular pethedine in controlling post operative pain in appendectomy and inguinal hernia
Purpose
Treatment
Inclusion/Exclusion criteria
Patients underwent appendectomy and inguinal hernia in the age group of 18-70 years. Pregnant women, patients with neurological disease or psychiatric disorders, with history of seizure, with acute or chronic kidney disease, history of gastrointestinal ulcer, drug users Psychotropic substances users or alchohol consumption and those with hemorrhoids or anus disorder were not included in the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
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
The Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil Complex Univesity, Daneshgah st, Ardabil
City
ardabil
Postal code
5618985991
Approval date
2013-04-28, 1392/02/08
Ethics committee reference number
arums.rec.1392.7
Health conditions studied
1
Description of health condition studied
postoperative pain control in appendectomy
ICD-10 code
k35, k36,
ICD-10 code description
Diseases of appendix
2
Description of health condition studied
postoperative pain control in inguinal hernia
ICD-10 code
k40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
pain
Timepoint
In the hours 2,6,12,24 after surgery
Method of measurement
To measure the final outcome of the study patient pain score was based on the visual analogue score criteria with metric roler ranged from zero to ten according to the variables table
Secondary outcomes
1
Description
patients sedation score
Timepoint
during the 2 nd,6th,12th,24th hours after surgey
Method of measurement
to score the patients sedation ramsy sedation score was used
2
Description
nausea and vomiting
Timepoint
during the 2 nd,6th,12th,24th hours after surgey
Method of measurement
The amont of N&V were measured according to N&V score
Intervention groups
1
Description
In the first group, suppository morphine 10 mg was administered at hours 2 nd, 6th, 12th and 24th after surgery.
Category
Treatment - Drugs
2
Description
In the second group, diclofenac suppository was given 100 mg at 2 nd, 6th, 12th, and 24th hours after surgery.
Category
Treatment - Drugs
3
Description
In the control group or the third group, if the patient had postoperative pain and the patient had a pain score above 4, 50 mg intramusclar pethidine was used to control pain.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
DR.Fatemi Hospital Ardabil
Full name of responsible person
DR.Ghodrat Akhavan Akbari
Street address
Ardabil Complex Univesity, Daneshgah st, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy Research of Ardabil University of Medical Sciences
Full name of responsible person
Dr.Shahram Habibzade
Street address
Ardabil Complex Univesity, Daneshgah st, Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Research of Ardabil University of Medical Sciences