Acute Pain
Conditions
Brief summary
A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjutant Pain Control Following Acute Rib Fractures.
Detailed description
Traumatic rib fractures are a tremendous source of pain which can limit respiratory function and overall recovery. Numerous multimodal pain management strategies have been employed with varying success; however, narcotics remain the mainstay of treatment. Beyond the acute side effects of narcotics, including altered mental status, depression of respiratory drive, and constipation, there is a substantial risk of long term dependency. Recently, loco-regional blockade and non-narcotic adjuncts have received increasing support within the literature. Gabapentin has been used extensively as a non-narcotic adjunct to analgesia regimens in the acute and chronic settings, however its ability to better control pain secondary to traumatic rib fractures has never been studied . The primary aim is to assess the efficacy of gabapentin as an analgesic after rib fractures. Secondary aims are to assess the effect on pulmonary function and other known complications following rib fractures. The hypothesis is gabapentin will improve pain control as measured by lower pain scores and lower narcotic needs. The investigators plan to test this hypothesis by recruiting trauma patients with rib fractures, and randomly assign them to gabapentin versus a placebo.
Interventions
DRUGGabapentin
Gabapentin 300 mg three times daily x30 days
Sponsors
University of Colorado, Denver
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* \> 1 rib fractures * Requiring hospital admission * Enrolled within 24 hours of injury
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Pain Score | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic requirements | 30 days | measurement of daily narcotic use as 24 hour requirements of morphine equivalents, and duration of narcotic needs. |
| pulmonary function | 30 days | assessment of the incidence of pneumonia (defined clinically by the treatment team), the incidence of hypoxemia, as well as readmission for pulmonary compromise. |
Countries
United States
Outcome results
None listed