The aim of the present study was to determine the efficacy of sub lingual Buprenorphin versus morphine injection in acute pain management and severity of withdrawal syndrome in addicted patients with acute abdomen
In a single-blind, Randomized study, 68 addicted patients undergoing laparatomy will randomized to receive either 0.4 mg of sub lingual buprenorphine or 5 mg of intravenous morphine four times/day. The patients will monitored for postoperative pain based on visual analog scale (VAS) and severity of withdrawal syndrome based on COWS in a period of 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080117811N5
Registration date:2014-08-08, 1393/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-08, 1393/05/17
Registrant information
Name
Shayan Amjadi
Name of organization / entity
Students Research Committee,Arak Universiry of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.amjadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Office of Vice Chancellor for Research
Expected recruitment start date
2013-05-10, 1392/02/20
Expected recruitment end date
2014-06-10, 1393/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of morphine and Buprenorphin in acute pain management in patients with acute abdoman
Public title
Buprenorphin and pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: continuous use of opiate in last 10 days ; acute pain due to acute abdomen ; indication of use of narcotics ; Patients of American Society of Anesthesiologists (ASA) physical status I ; age 20-60
exclusion criteria: age less than 20 or more than 60 ;paracetamol prescription during last hour ; narcotics overdose ; undiagnosed acute abdomen ; multiple billiary duct stone ; los of conciseness due to head trauma ; shock ; underlying disease effects on pain ; SBP<100 ; multi drug dependants
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of medical science
Street address
Arak University of medical science,sardasht,arak,iran
City
Arak
Postal code
Approval date
2013-02-01, 1391/11/13
Ethics committee reference number
91-142-6
Health conditions studied
1
Description of health condition studied
acute abdominal pain
ICD-10 code
R10.0
ICD-10 code description
Severe abdominal pain (generalized)(localized)(with abdominal rigidity)
2
Description of health condition studied
opiate dependent patients
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
pain severity
Timepoint
hour 1 , 6 and 24 after surgery
Method of measurement
visual analog scale (VAS)
2
Description
withdrawal severity
Timepoint
hour 1 , 6 and 24 after surgery
Method of measurement
Clinical Opiates Withdrawal Scale(COWS)
Secondary outcomes
empty
Intervention groups
1
Description
0.4 mg of sub lingual buprenorphinee 4 times/day
Category
Treatment - Drugs
2
Description
5 mg of intravenous morphine 4 times/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr.Solhi
Street address
Valiasr hospital , Arak , Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Science,Office of Vice Chancellor for Research
Full name of responsible person
Mohammad Rafii
Street address
Arak univercity of medical science , Arak , Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Science,Office of Vice Chancellor for Research
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
Students Research Committe , Medicine faculty , Aarak University of Medical Science
Full name of responsible person
Reza Behzadi
Position
Medical student
Other areas of specialty/work
Street address
Arak University of Medical Science , Sardasht , Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
rezabehzadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Toxicology Department , Medicine faculty, Arak university of medical science
Full name of responsible person
Hasn Solhi
Position
Forensic Science and poisoning specialist ,Associate Professor
Other areas of specialty/work
Street address
Arak University Of Medical Science, Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
Dr.solhi@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Students Research Committee , Arak University of Medical Science
Full name of responsible person
Reza Behzadi
Position
Medical student
Other areas of specialty/work
Street address
Arak University of Medical Science , Sardasht , Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
rezabehzadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)