Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures
A Multicenter, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures
1 other identifier
interventional
100
1 country
1
Brief Summary
A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjutant Pain Control Following Acute Rib Fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2018
CompletedOctober 26, 2018
October 1, 2018
2.1 years
July 15, 2016
October 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Average Daily Pain Score
the pain score uses the visual analog scale and ranges from 0 to 10. This is recorded by nursing at pre-specified intervals depending on level of care.
30 days
Secondary Outcomes (2)
Narcotic requirements
30 days
pulmonary function
30 days
Study Arms (2)
gabapentin
EXPERIMENTALgabapentin 300 mg three times daily x 30 d
placebo
NO INTERVENTIONno gabapentin administered to this arm.
Interventions
Eligibility Criteria
You may qualify if:
- \> 1 rib fractures
- Requiring hospital admission
- Enrolled within 24 hours of injury
You may not qualify if:
- Pregnancy
- Intubation
- Age \<18, age \>65
- Inability to tolerate PO medication
- Patient refusal
- Inability to obtain consent from patient or surrogate
- Renal or Hepatic impairment
- Allergy or Hypersensitivity to gabapentin or any component of the formulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Denver Health Medical Center
Denver, Colorado, 80204, United States
Related Publications (2)
Sirmali M, Turut H, Topcu S, Gulhan E, Yazici U, Kaya S, Tastepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. doi: 10.1016/s1010-7940(03)00256-2.
PMID: 12853057BACKGROUNDChapman BC, Herbert B, Rodil M, Salotto J, Stovall RT, Biffl W, Johnson J, Burlew CC, Barnett C, Fox C, Moore EE, Jurkovich GJ, Pieracci FM. RibScore: A novel radiographic score based on fracture pattern that predicts pneumonia, respiratory failure, and tracheostomy. J Trauma Acute Care Surg. 2016 Jan;80(1):95-101. doi: 10.1097/TA.0000000000000867.
PMID: 26683395BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fredric M Pieracci, MD, PMPH
Denver Health
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2016
First Posted
August 5, 2016
Study Start
October 1, 2016
Primary Completion
October 23, 2018
Study Completion
October 23, 2018
Last Updated
October 26, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share