The Effect of Neurontin on Pain Management in the Acutely Burned Patient
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Purpose
Burn patients have extreme pain. Opioids are the main agents used for analgesia. Opioids can have several adverse outcomes and have been only partially effective in controlling the pain assoicated with burn injury. Agents directed at neuropathic pain are rarely used acutely in thermal injury. However, there is mounting evidence from small randomized clinical studies that the administration of the anticonvulsant Gabapentin decreases acute burn pain and has an opioid sparing effect. We therefore propose a single center study to fruther assess the efficacy of neuropathic agents in controlling the pain assoicated with acute thermal injury.
| Condition | Intervention |
|---|---|
|
Pain Management Burn Patient |
Drug: Gabapentin Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | The Effect of Neurontin on Pain Management in the Acutely Burned Patient |
- To determine the trends in opioid consumption between the treatment and the control groups. [ Time Frame: From time of enrollment to 2 weeks after being discharged ] [ Designated as safety issue: No ]
- To determine the trends in several associated clinical effects of opioid administration between the treatment and the control groups. These effects include: 1. Fluid resusitation 2. insulin resistance 3. Hospital associated infections [ Time Frame: From time of enrollment to 2 weeks after being discharge ] [ Designated as safety issue: No ]
- To determine the impact of psychological functioning in patients following admission for their burn injury. This will be determined by review of two forms (the brief Symptom inventory and the sickness impact profile). [ Time Frame: From time of enrollment to 2 weeks after being discharge ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Sugar Pill |
Drug: Placebo
Sugar Pill is administered similar to the protocol used for the investigational drug.
|
| Experimental: Gabapentin |
Drug: Gabapentin
On Study day 1: 1200mg (single dose). Study day 2,3: 300mg TID, 900mg daily. Study day 4-7: 600mg TID 1800mg* daily. Study day 8-11: 800mg TID 2400mg* daily [Optional increase to 2400 if pain scores are still 4 on NRS] Study day 11: 1200mg TID 3600mg* daily [Optional increase to 3600 if pain scores are still >4 on NRS] * May revert back to prior dose if adverse symptoms occur and are thought to be drug related. Up titration then will be preformed in 48 hours following deexcalation. Other Name: Neurontin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All admitted patients with LOS expected to be > 48 hours (usually burn injury > 5%)
- > 18 years of age
- Thermal injury to skin
Exclusion Criteria:
- Prisoners
- Pregnant or nursing women
- Children <18 years of age
- Frostbite or non thermal injury to skin
- Renal insuffiency (creatinine clearance < 60mL/min) or failure (on renal replacement)
- Expected length of stay < 48 hours (this usually includes burn <5%
Contacts and Locations| Contact: Anas A Eid, MD | 3193561304 | anas-eid@uiowa.edu |
| United States, Iowa | |
| University of Iowa Burn Center | Recruiting |
| Iowa City, Iowa, United States, 52241 | |
| Principal Investigator: | Lucy Wibbenmeyer, MD | University of Iowa |
| Study Director: | Anas Eid, MD | University of Iowa |
More Information
Publications:
| Responsible Party: | Lucy Wibbenmeyer, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT01265056 History of Changes |
| Other Study ID Numbers: | 200909736 |
| Study First Received: | December 20, 2010 |
| Last Updated: | December 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on October 18, 2012
