Gabapentin in Phantom and Stump Pain
Information source: Danish Pain Research Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amputation of Lower Limb
Intervention: Gabapentin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Danish Pain Research Center Official(s) and/or principal investigator(s):
Lone Nikolajsen, MD, PhD, Principal Investigator, Affiliation: Danish Pain Research Center
Summary
To investigate whether gabapentin can prevent phantom and stump pain after amputation.
Clinical Details
Official title: Gabapentin in the Prevention of Phantom Limb Pain
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Primary outcome measures:Number of patients with phantom and stump pain 30 days and 6 months after amputation Average intensity of stump and phantom pain 30 days and 6 months after amputation
Secondary outcome: Secondary outcome measures:Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Amputation of crus or femur
Exclusion Criteria:
1. Patients who cannot cooperate
2. Fertile women without sufficient contraceptives
3. Allergy to gabapentin
4. Earlier amputation of the same limb except toes
5. Serious lever, kidney, cardiac, respiratory, haematological disease.-
Locations and Contacts
Danish Pain Research Center, Aarhus University Hospital, Aarhus 8000, Denmark
Additional Information
Danish Pain Research Center
Starting date: May 2002
Ending date: June 2006
Last updated: April 11, 2007
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