Protocol summary

Summary
Objectives: To investigate the effects of morphine and methadone for pain control after orthopedic surgery in patients addicted to opioids. Research Design: A randomized, double-blind, clinical trial Inclusion criteria: Opium -addicted patients, aged of 18-70 years undergoing major orthopedic surgeries. Exclusion criteria: Patients with a history of myocardial infarction, heart failure, patients with ASA above III, using anti-depressant, allergy to the drugs and patients requiring ICU after surgery.68 Patients are randomly divided into two groups MTD (methadone) and M (morphine).However,0.15 mg/kg morphine or methadone given to the patient an hour before the completion of the surgery. Patients in recovery room were treated according to the severity of pain as follows: morphine 1 mg every 5 minutes with pain score 6-4, and 2 mg every 5 minutes with pain score of 10 -7.While, blood pressure and breathing were monitoring, until the pain intensity reaches to less than 4. In the surgery ward morphine pump was used for patients in the both groups, as follows ,a solution of 20 cc, 0.5 mg per/cc with 1 mg or 2 CC bolus and interval locked out seven minutes and the maximum dose of 25 mg or 50 cc every 4 hours.At 0, 1, 3, 6 and 24 hours after surgery pain parameters (both in the time of the rest and activity), pruritus, nausea and vomiting, urinary retention, sedation and degree of patient satisfaction measured and data were recorded in a special form. Pain Score, patient satisfaction and degree of sedation were measured via NRS, four point categorical scale and Wilson, respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100919470N1
Registration date: 2015-01-09, 1393/10/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-09, 1393/10/19
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2014-02-01, 1392/11/12
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Postoperative Pain in Major Orthopedic Surgery in Patients Addicted to Opium.
Public title
Comparison of Morphine and Methadone on Postoperative Pain of Opioid Addicted Patients in Major Orthopedic Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: opium -addicted patients, aged of 18-70 years undergoing major orthopedic surgeries. Exclusion criteria: patients with a history of myocardial infarction, heart failure, patients with ASA class above III, patients using anti-depressant drugs, a history of allergy to the drugs and patients who need ICU after surgery.
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: 68
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CP-P-9356-5676

Health conditions studied

1

Description of health condition studied
Opium Addiction
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids

2

Description of health condition studied
Orthopaedic Surgery
ICD-10 code
M96.6
ICD-10 code description
Fracture of Bone following Insertion of Orthopaedic Implant, Joint Prosthesis, or Bone Plate

Primary outcomes

1

Description
Evaluation of the postoperative pain in major orthopedic surgery in patients addicted to opium.
Timepoint
Immediately after surgery and one hour, three hours, six hours and 24 hours after surgery.
Method of measurement
NRS

Secondary outcomes

1

Description
Patient's satisfaction
Timepoint
Immediately after surgery and one hour, three hours, six hours and 24 hours after surgery.
Method of measurement
Four Point Categorical Scale

Intervention groups

1

Description
Intervention Group 1: 0.15 mg/kg Morphine Given to the Patients an Hour before the Completion of the Surgery
Category
Treatment - Drugs

2

Description
Intervention Group 1: 0.15 mg/kg Methadone Given to the Patients an Hour before the Completion of the Surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Afsoon Aleepour
Street address
Chamran Hospital, Chamran Boulevard
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Afsoon Aleepour
Position
Physician, Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3235 7282
Fax
Email
afsoonaalipoor@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Hedayatollah Akhlagh
Position
Anesthesiologist, Pain Fellowship
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
akhlaghh@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
English Consultant,Anesthesiology Research Center Staff
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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