Investigating the effect of Buprenorphine on pain in the acute phase of patients with mild to moderate Traumatic Brain Injury: A double-blind clinical trial
Investigation of the effect of buprenorphine drug on pain in the acute phase of patients with mild to moderate brain trauma
Design
This study is a double-blind randomized clinical trial that classifies participants into parallel groups using four- and six-person blocks and is performed on 102 individuals with mild to moderate brain damage. The intervention group receives medication, while the control group receives a placebo.
Settings and conduct
This study is being conducted on patients with brain injury who are referred to Shahid Sadegh Ganji Hospital in Borazjan and is of a double-blind, randomized clinical trial type, where both the researcher and patients are unaware of the drug or placebo being used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 65 with mild to moderate brain trauma (GCS score of 9 or higher).
Exclusion criteria: Patients with penetrating head trauma, time elapsed from injury to hospital admission more than 4 hours, associated spinal cord injury, candidate for craniotomy, concomitant injuries and opioid substance abuse. Patients with cardiovascular diseases accompanied by hemodynamic instability. History or diagnosis of various types of cancer.
Intervention groups
The intervention group takes an 8mg dose of buprenorphine orally, while the control group takes a placebo orally.
Main outcome variables
The Visual Analogue Scale (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240603061997N1
Registration date:2024-06-11, 1403/03/22
Registration timing:prospective
Last update:2024-06-11, 1403/03/22
Update count:0
Registration date
2024-06-11, 1403/03/22
Registrant information
Name
Mohammad Hossein Niazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 5000
Email address
niamh6375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Buprenorphine on pain in the acute phase of patients with mild to moderate Traumatic Brain Injury: A double-blind clinical trial
Public title
Investigating the effect of Buprenorphine on pain in the acute phase of patients with mild to moderate Traumatic Brain Injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 65 with mild to moderate brain injury severity, as determined by a Glasgow Coma Scale (GCS) score of 9 and above
Exclusion criteria:
Patients with penetrating head trauma, time from injury to hospital admission more than 4 hours, associated spinal cord injury, candidate for craniotomy, concomitant with other traumas and opioid substance abuse. Associated with cardiovascular diseases along with hemodynamic instability. History or incidence of various cancers.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning, patients are randomly divided into two groups, control and intervention, using online software at www.sealedenvelope.com in blocks of 4 and 6 members equally(each group has 50 members); this is done by one of the emergency department secretaries, and patients are unaware of this division. After registering the initial demographic information of the patients by a neurosurgeon who is unaware of the patient division, the control group receive standard treatment and are followed up, while the intervention group, in addition to the standard treatment, receive 8 milligrams of buprenorphine orally in a single dose and then are followed up.
Blinding (investigator's opinion)
Double blinded
Blinding description
A person who randomizes patients has given the drug or its placebo to the researcher, and due to the similar appearance of the drugs, the researcher will not be able to distinguish between the two drugs. The patient is also unaware of the type of drug they are taking.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
South Sheikh Bahayi Ave., Mollasadra Ave., Vanak Sq.
If the patient confirms any side effects of the drug "Yes" otherwise "No"
Intervention groups
1
Description
Intervention group: One tablet of 8 mg buprenorphine orally, single dose, is administered to patients in the intervention group once after hospital admission.
Category
Treatment - Drugs
2
Description
Control group: Placebo consumption, orally, once after hospital admission, is administered to patients in the control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadegh Ganji Hospital, Borazjan (Bushehr University of Medical Sciences)
Full name of responsible person
Mahammad Eslamian
Street address
Sadegh Ganji Hospital, Emam Reza Sq.
City
Borazjan
Province
Boushehr
Postal code
7561783617
Phone
+98 77 3426 0010
Email
md.eslamian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mousareza Anbarlouei
Street address
South Sheikh Bahayi Ave., Mollasadra Ave., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
Mousareza.anbarlouei@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mahammad Eslamian
Street address
Sadegh Ganji Hospital, Emam Reza Sq.
City
Borazjan
Province
Boushehr
Postal code
7561783617
Phone
+98 77 3426 0010
Email
md.eslamian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
50
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
موسی رضا انبارلوئی
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
South Sheikh Bahayi Ave., Mollasadra Ave., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 3999
Email
Mousareza.anbarlouei@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mousareza Anbarlouei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
South Sheikh Bahayi Ave., Mollasadra Ave., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 3999
Email
Mousareza.anbarlouei@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mousareza Anbarlouei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
South Sheikh Bahayi Ave., Mollasadra Ave., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 3999
Email
Mousareza.anbarlouei@bmsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available