The Effect of Neurontin on Pain Management in the Acutely Burned Patient
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.
|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 ]
|Study Start Date:||February 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Sugar Pill||
Sugar Pill is administered similar to the protocol used for the investigational drug.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265056
|United States, Iowa|
|University of Iowa Burn Center|
|Iowa City, Iowa, United States, 52241|
|Principal Investigator:||Lucy Wibbenmeyer, MD||University of Iowa|
|Study Director:||Karen Kluesner, RN||University of Iowa|