Comparison of efficacy and side effects of morphine and diclofenac suppositories in post operative pain after appendectomy and inguinal hernia surgery in Fatemi hospital
The aim of study is compare morphine suppository with a drug less harmful and beneficial (in terms of pain reduction) such as diclifenac suppository and found efficacy and side effects of morphine suppositories.
Material and Methods : In this study, 75 patients with inguinal hernia surgery and appendectomy were randomly divided into 3 groups and 25 patients in each: first group received morphine suppositories (10mg) and the second group received diclofenac suppository (100mg) in 2, 6, 12, 24 hours and if VAS>4.0, received injective pethidine. In third group, to control of pain (VAS>4) received intramuscular pethidine (50mg) Prn.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012103111338N1
Registration date:2014-05-24, 1393/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-24, 1393/03/03
Registrant information
Name
Godrat Akhavan Akbari
Name of organization / entity
Ardabil University of Medical Sciences, Fatemi Hospital Of Ardabil
Country
Iran (Islamic Republic of)
Phone
+98 45 1223 3032
Email address
g.akbari@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and side effects of morphine and diclofenac suppositories in post operative pain after appendectomy and inguinal hernia surgery in Fatemi hospital
Public title
Efficacy and complications of morphine suppository
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who are candidates for appendectomy and inguinal hernia surgery ؛Patients aged 70-18 years؛Patients without underlying disease and drug consumption
Exclusion criteria: Pregnant patients؛ patients with neurological disease or psychiatric disorders, patients with a history of seizures؛ patients with acute or chronic renal disease؛ patients with a history of peptic ulcer ؛ patients with taking psychotropic drugs؛ abused alcohol or opioid drugs؛,Hemorrhoid disease or disorder in anus
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
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
Ardabil University of Medical Sciences
Street address
Ardabil
City
Ardabil
Postal code
Approval date
2013-04-28, 1392/02/08
Ethics committee reference number
ARUMS.REC.92.7
Health conditions studied
1
Description of health condition studied
acute postoperative pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain intensity(VAS)
Timepoint
in 2, 6, 12, 24 hours post operation
Method of measurement
based on graded ruler 0-10
Secondary outcomes
1
Description
1-sedation 2-nausea and vomiting
Timepoint
in 2, 6, 12, 24 hours post operation
Method of measurement
based on Ramsay Sedation Scale(0-5)
Intervention groups
1
Description
first group received morphine suppositories (10mg) in 2, 6, 12, 24 hours post operation if VAS>4.0
Category
Treatment - Drugs
2
Description
second group received diclofenac suppositories (100mg) in 2, 6, 12, 24 hours post operation if VAS>4.0
Category
Treatment - Drugs
3
Description
In third group, to control of pain (VAS>4) received intramuscular pethidine (50mg) Prn
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital of Ardabil
Full name of responsible person
Godrat Akhavan Akbari
Street address
Emam Khomeyni Street, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Godrat Akhavan Akbari
Street address
Emam Khomeyni Street, Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Godrat Akhavan Akbari
Position
pain fellowship-lecturer
Other areas of specialty/work
Street address
fatemi hospital of ardabil
City
Ardabil
Postal code
Phone
+98 45 1223 2521
Fax
Email
g.akbari@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Godrat Akhavan Akbari
Position
pain fellowship-Associate professor
Other areas of specialty/work
Street address
Emam Khomeyni Street, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1223 2521
Fax
Email
g.akbari@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Godrat Akhavan Akbari
Position
pain fellowship-Associate professorr
Other areas of specialty/work
Street address
Emam Khomeyni Street, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1223 2521
Fax
Email
g.akbari@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)