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Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study.

Abstract

A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p=0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p=0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p=0.0016). Both the Patient (p=0.023) and Clinician (p=0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness.

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  • Authors+Show Affiliations

    ,

    Multidisciplinary Pain Center, Uppsala University Hospital, S-751 85 Uppsala, Sweden. torsten.gordh@akademiska.se

    , , , , , , ,

    Source

    Pain 138:2 2008 Aug 31 pg 255-66

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Amines
    Cross-Over Studies
    Cyclohexanecarboxylic Acids
    Double-Blind Method
    Female
    Gabapentin
    Humans
    Internationality
    Male
    Middle Aged
    Neuralgia
    Pain Measurement
    Peripheral Nerve Injuries
    Peripheral Nerves
    Trauma, Nervous System
    gamma-Aminobutyric Acid

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    18258368

    Citation

    Gordh, Torsten E., et al. "Gabapentin in Traumatic Nerve Injury Pain: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study." Pain, vol. 138, no. 2, 2008, pp. 255-66.
    Gordh TE, Stubhaug A, Jensen TS, et al. Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study. Pain. 2008;138(2):255-66.
    Gordh, T. E., Stubhaug, A., Jensen, T. S., Arnèr, S., Biber, B., Boivie, J., ... Kalso, E. (2008). Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study. Pain, 138(2), pp. 255-66. doi:10.1016/j.pain.2007.12.011.
    Gordh TE, et al. Gabapentin in Traumatic Nerve Injury Pain: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study. Pain. 2008 Aug 31;138(2):255-66. PubMed PMID: 18258368.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study. AU - Gordh,Torsten E, AU - Stubhaug,Audun, AU - Jensen,Troels S, AU - Arnèr,Staffan, AU - Biber,Björn, AU - Boivie,Jörgen, AU - Mannheimer,Clas, AU - Kalliomäki,Jarkko, AU - Kalso,Eija, Y1 - 2008/02/06/ PY - 2007/04/22/received PY - 2007/11/23/revised PY - 2007/12/17/accepted PY - 2008/2/9/pubmed PY - 2009/1/27/medline PY - 2008/2/9/entrez SP - 255 EP - 66 JF - Pain JO - Pain VL - 138 IS - 2 N2 - A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p=0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p=0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p=0.0016). Both the Patient (p=0.023) and Clinician (p=0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness. SN - 1872-6623 UR - https://www.unboundmedicine.com/medline/citation/18258368/Gabapentin_in_traumatic_nerve_injury_pain:_a_randomized_double_blind_placebo_controlled_cross_over_multi_center_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0304-3959(07)00751-8 DB - PRIME DP - Unbound Medicine ER -