Comparison of sublingual buprenorphine and intravenous morphine in pain relief and side effects in patients with primary headache admitted in emergency department
Object: comparison of sublingual buprenorphine and intravenous morphine in pain relief and side effects in patients with primary headache admitted in emergency department.
Design: randomized (randomized numbers), double blind, placebo, single center.
Target sample size: 140
Exclusion criterias: patients with convulsion; cardiac disorder; liver disorder; nephrogenic disorder; metabolic disorder; temperature more than 38; patients with unstable vital sign (blood pressure under 90); pregnancy; patients with drug addiction; patients with allergy to opioid; patients who get opioid 6 hours before admit to mergency; age under 18 and age upper 55; patients who would not like arrive to study.
Inclusion criterias: patients with age 15; 55 years old.
Setting and conduct: we measure pain with Numeric rating scale (NRS), patients divide To two groups, control group (M group) who get intravenous morphine 0.1 mg per kg and sublingual placebo, intervention group (B group) who get sublingual buprenorphine 2mg and intravenous placebo then pain measure in times 0, 20, 40, 60 Mminutes after get drug with Numeric rating scale.
Out come: without Pain with drug with less complication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030821379N1
Registration date:2015-07-06, 1394/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Mehdi Hadipourzadeh
Name of organization / entity
Ahwaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3554 4621
Email address
hadipourzadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Ahwaz University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sublingual buprenorphine and intravenous morphine in pain relief and side effects in patients with primary headache admitted in emergency department
Public title
Comparison of sublingual buprenorphine and intravenous morphine in pain relief and side effects in patients with primary headache admitted in emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criterias: Patients with convulsion; cardiac disorder; liver disorder; nephrogenic disorder; metabolic disorder; temperature more than 38; patients with unstable vital sign (blood pressure under 90); pregnancy; patients with drug addiction; patients with allergy to opioid; patients who get opioid 6 hours before admit to emergency; age under 18 and age upper 55; patients who would not like arrive to study
Inclusion criterias: patients with age 18; 55 Years old
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
Ahwaz University of Medical Sciences, Golestan, Ahwaz
Intervention group who get sublingual buprenorphine 2mg and intravenous placebo then pain measure in times 0, 20, 40, 60 minutes after get drug With Numeric Rating Scale
Category
Treatment - Drugs
2
Description
Control group who get intravenous morphine 0.1 mg per kg and sublingual placebo, Then pain measure in Times 0, 20, 40 , 60 minutes after get drug with Numeric rating scale
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr Hasan Barzegari
Street address
Golestan hospital, Golestan, Ahwaz
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Ahwaz University of Medical Sciences
Full name of responsible person
Dr nader saki
Street address
Ahwaz University of Medical Sciences, Golestan, Ahwaz
City
Ahwaz
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 of Ahwaz 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
Ahwaz University of Medical Sciences
Full name of responsible person
Dr Hasan Barzegari
Position
Assistant professor of Emergency
Other areas of specialty/work
Street address
Ahwaz University of Medical Sciences, Golestan, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3554 4621
Fax
Email
h_b1979@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz University of Medical Sciences
Full name of responsible person
Dr Hasan Barzegari
Position
Assistant professor of Emergency
Other areas of specialty/work
Street address
Ahwaz University of Medical Sciences, Golestan, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3222 5763
Fax
Email
h_b1979@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz University of Medical Sciences
Full name of responsible person
Dr Hasan Barzegari
Position
Assistant professor of Emergency
Other areas of specialty/work
Street address
Ahwaz University Of Medical Sciences, Golestan, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3554 4621
Fax
Email
h_b1979@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)