Analgesic effects of morphine suppository versus intravenous morphine in patients with extremity bone fracture: A placebo-controlled double-blind randomized clinical trial
Objectives: Pain management is one of the major tasks of any emergency department. Finding a way to better control of pain can result in decreasing staff workload and increasing patient's satisfaction.
Design:This is a double blind randomized placebo controlled clinical trial.
setting:This study will be conducted patients with acute extremity fracture with age between 18-70 referred to our emergency departments.Patients with recent use of opiate; patients with severe liver, renal,lung disease; patients with sensitivity to morphine will be excluded.They will divided randomly into two group. First group will receive intravenous morphine 5 mg with placebo suppository and second group will receive 5cc Distilled water with suppository morphine.Then the patients will be examined from the view point of pain score in 0,15,60 minutes and after1,3,6,12,18,24 hours and need foe rescue analgesia and side effects. Assessment of pain will be done with Visual analogue scale (VAS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505218104N12
Registration date:2017-08-20, 1396/05/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Mohammad Amin Zare
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
ma-zare@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of research, Iran University of Medical Sciences
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic effects of morphine suppository versus intravenous morphine in patients with extremity bone fracture: A placebo-controlled double-blind randomized clinical trial
Public title
Acute pain control with morphine suppository
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
trauma patients with acute extremity fracture
between 18 and 70 years old who have moderate to severe pain according to their visual analogue scale (VAS) score (score equal or higher than 5 of 10)
Exclusion Criteria:
known opioid allergy, a history of current/past drug abuse, other concurrent causes of pain (including trauma to other site), history of any chronic diseases (like respiratory, renal, hepatic, or heart failure), any conditions impairing the patient’s cooperation and participation in study (including altered consciousness, mental disorders and language barrier), pregnant and breastfeeding women and patients who had received analgesics 24 hours before admission
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
224
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
multi-center
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat and Sheikh Fazlollah highways cross
City
Tehran
Postal code
14457
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.IUMS.REC.1394.9211307035
Health conditions studied
1
Description of health condition studied
Pain in extrimity fracture
ICD-10 code
XIX
ICD-10 code description
Injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
Severity of pain
Timepoint
0.30.60 minutes and 1,3,6,12,18,24 hour
Method of measurement
numerical criteria on the base of VAS score
Secondary outcomes
1
Description
Apnea,decreased Oxygen suturation, decreased level of consciousness, decreased blood pressure, nausea and vomiting
Timepoint
0-30-60 minutes and 1,3,6,12,18,24 hour
Method of measurement
Checking the patients respiratory rate, Oxygen saturation on pulse oximetry, checking blood pressure and asking about nausea and vomiting
Intervention groups
1
Description
Control group will receive intravenous morphine 5 mg and placebo suppository .
Category
Treatment - Drugs
2
Description
Case group will receive 10 mg suppository morphine and 5 ml of intravenous distilled water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Mohammad Amin Zare
Street address
Niyayesh St, Sattarkhan Ave
City
Tehran
2
Recruitment center
Name of recruitment center
Haft-e-tir hospital
Full name of responsible person
Mohammad Amin Zare
Street address
Shahre Rey-Shahid Radjayi Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research of Iran University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Eftekhar
Street address
Hemmat and Sheikh Fazlollah cross
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hoda Taghipour
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Hemmat and Sheikh Fazlollah highways cross
City
Tehran
Postal code
1449614535
Phone
+98 21 8805 2963
Fax
Email
negareirani1983@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Amin Zare
Position
Associate professor
Other areas of specialty/work
Street address
Hemmat and Sheikh Fazlollah highways cross
City
Tehran
Postal code
1449614535
Phone
+98 21 8805 2963
Fax
Email
mazare74@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hoda Taghipour
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Hemmat and Sheikh Fazlollah highways cross
City
Tehran
Postal code
1449614535
Phone
+98 21 8805 2963
Fax
Email
negareirani1983@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)