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Investigating the effect of Buprenorphine on pain in the acute phase of patients with mild to moderate Traumatic Brain Injury

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240603061997N1
Enrollment
102
Registered
2024-06-11
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate Traumatic Brain Injury. Intracranial injury

Interventions

Intervention 1: Intervention group: One tablet of 8 mg buprenorphine orally, single dose, is administered to patients in the intervention group once after hospital admission. Intervention 2: Control g

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor
Boushehr University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Score of the Visual Analogue Scale (VAS). Timepoint: Day 1 and 14 after taking medication. Method of measurement: Visual analogue scale (VAS).;Score of Glasgow Outcome Scale Extended (GOSE). Timepoint: Day 1 and 14 after taking medication. Method of measurement: Glasgow Outcome Scale Extended (GOSE) Questionnaire.

Secondary

MeasureTime frame
Score of The Working Memory Questionnaire. Timepoint: Day 1 and 14 after taking medication. Method of measurement: The Working Memory Questionnaire.;Side effects related to the drug. Timepoint: Day 1 and 14 after taking medication. Method of measurement: If the patient confirms any side effects of the drug "Yes" otherwise "No".

Countries

Iran (Islamic Republic of)

Contacts

Public Contact???? ??? ?????????

Bagheiat-allah University of Medical Sciences

Mousareza.anbarlouei@bmsu.ac.ir+98 21 8126 3999

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026