The Effect of Neurontin on Pain Management in the Acutely Burned Patient | RxWiki

The Effect of Neurontin on Pain Management in the Acutely Burned Patient

Overview[ - collapse ][ - ]

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	Pain Management Burn Patient
Intervention	Drug: Gabapentin Drug: Placebo
Phase	N/A
Sponsor	University of Iowa
Responsible Party	University of Iowa
ClinicalTrials.gov Identifier	NCT01265056
First Received	December 20, 2010
Last Updated	January 22, 2013
Last verified	January 2013

Tracking Information[ + expand ][ + ]

First Received Date	December 20, 2010
Last Updated Date	January 22, 2013
Start Date	February 2010
Estimated Primary Completion Date	September 2011
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	The Effect of Neurontin on Pain Management in the Acutely Burned Patient
Official Title	The Effect of Neurontin on Pain Management in the Acutely Burned Patient
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Pain Management Burn Patient
Intervention	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 Names: NeurontinDrug: Placebo Sugar Pill is administered similar to the protocol used for the investigational drug.
Study Arm (s)	Placebo Comparator: Sugar Pill Experimental: Gabapentin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	53
Estimated Completion Date	September 2011
Estimated Primary Completion Date	September 2011
Eligibility Criteria	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%
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01265056
Other Study ID Numbers	200909736
Has Data Monitoring Committee	No
Information Provided By	University of Iowa
Study Sponsor	University of Iowa
Collaborators	Not Provided
Investigators	Principal Investigator: Lucy Wibbenmeyer, MD University of IowaStudy Director: Karen Kluesner, RN University of Iowa
Verification Date	January 2013

Locations[ + expand ][ + ]