Comparing the effect of morphine and methadone on control the postoperative pain in opium addict patients undergoing orthopedic surgery.
Design
A randomized, parallel, clinical trial with blinded care provider, outcome assessment and the patient
Settings and conduct
This randomized, double-blinded study will be performed in a tertiary healthcare center which is a referral center for orthopedic surgery. All the patients will be randomized to two study groups to receive morphine (0.15 mg/kg) or methadone (0.15 mg/kg) during the operation.
Participants/Inclusion and exclusion criteria
Opium-dependent patients, aging between 18-78 years scheduled for major orthopedic surgeries will be included. The patients with ASA class III and IV, those receiving antidepressant and anticonvulsant medications and those with a history of hypersensitivity reaction to methadone and morphine will be excluded.
Intervention groups
1. Intramuscular injection (deltoid muscle) of 0.15 mg/kg methadone hydrochloride one hour before termination of the surgery.
2. Intramuscular injection (deltoid muscle) of 0.15 mg/kg morphine sulphate hydrochloride one hour before termination of the surgery.
Main outcome variables
Postoperative pain, postoperative nausea and vomiting, need for rescue analgesic, drug adverse effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090912002445N7
Registration date:2018-05-21, 1397/02/31
Registration timing:retrospective
Last update:2018-05-21, 1397/02/31
Update count:0
Registration date
2018-05-21, 1397/02/31
Registrant information
Name
Fariborz Ghaffarpasand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4259
Email address
ghafarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2017-10-01, 1396/07/09
Actual recruitment start date
2016-10-01, 1395/07/10
Actual recruitment end date
2017-10-01, 1396/07/09
Trial completion date
empty
Scientific title
Effects of Intraoperative Morphine and Methadone on Postoperative Pain Control in Opioid Addicted Patients undergoing Orthopedic Surgery
Public title
Morphine and methadone for postoperative pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA Class I and II
Opium Addict
Elective orthopedic surgery
Exclusion criteria:
ASA Class III and IV
Preoperative antidepressant and anticoagulant medication
Hypersensitivity to morphine
Hypersensitivity to methadone
Age
From 18 years old to 78 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
All the patients will be randomized to two study groups using a computerized random digit generator based in the patients' admission number.
Blinding (investigator's opinion)
Double blinded
Blinding description
This will be a double-blinded randomized clinical trial. The medications will be prepared in the same form in dark syringes and will be given to the anesthesiologist who is not aware of the content. The nurse who will record the patient postoperative pain is also unaware of the study group. The patients are also blinded toward to study intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Avenue
City
Shiraz
Province
Fars
Postal code
71973–11351
Approval date
2016-03-03, 1394/12/13
Ethics committee reference number
IR.SUMS.MED.REC.1394.509
Health conditions studied
1
Description of health condition studied
After surgery pain
ICD-10 code
R52
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Postoperative pain
Timepoint
0, 1, 3, 6, 12, 24 hours after operation
Method of measurement
Visual analogue scale
2
Description
Postoperative nausea and vomitting
Timepoint
0, 1, 3, 6, 12, 24 hours after operation
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Need for rescue analgesia
Timepoint
24 hours after the surgery
Method of measurement
Administered dosage in milligrams
Intervention groups
1
Description
Intervention group: Intramuscular methadone (0.15 mg/kg) one hour before termination of surgery
Category
Treatment - Drugs
2
Description
Control group: Intramuscular morphine sulphate (0.15 mg/kg) one hour before termination of surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Reza Raeesi Estabragh
Street address
Chamran avenue
City
Shiraz
Province
Fars
Postal code
71973–11351
Phone
+98 71 3647 4270
Email
r.raeesi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Zand Avenue
City
Shiraz
Province
Fars
Postal code
71345-1876
Phone
+98 71 3235 7282
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Shiraz University of Medical Sciences
Full name of responsible person
Reza Raeesi Estabragh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology and Intensive Care Research Center, Nemazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3647 4270
Email
r.raeesi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Raeesi Estabragh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology and Intensive Care Research Center, Nemazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3647 4270
Email
r.raeesi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariborz Ghaffarpasand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Shahid Chamran hospital, Chamran Avenue
City
Shiraz
Province
Fars
Postal code
71345-1876
Phone
+98 71 3625 4206
Fax
Email
ghafarf@sums.ac.ir
Web page address
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