BACKGROUND: To evaluate the efficacy of gabapentin at 20 mg/kg per day in the treatment of vincristine-related neuropathic pain. PROCEDURE: Children aged 1-18 years who developed vincristine-induced neuropathy on a St Jude frontline acute lymphoblastic leukemia trial were prospectively enrolled on a randomized, double-blind, placebo-controlled, phase II trial with two treatment arms: gabapentin plus opioid versus placebo plus opioid. Daily evaluations of morphine dose (mg/kg per day) and pain scores were conducted for up to 21 days; the values of the two arms were compared to assess analgesic efficacy. RESULTS:Of 51 study participants, 49 were eligible for analyses. Twenty-five participants were treated with gabapentin, with a mean (SD) dose of 17.97 (2.76) mg/kg per day (median 18.26, range 6.82-21.37). The mean (SD) opioid doses taken, expressed as morphine equivalent daily (mg/kg per day), were 0.26 (0.43) in the gabapentin group (25 patients, 432 days) and 0.15 (0.22) in the placebo group (24 patients, 411 days; P = .15). Only the risk classification of acute lymphoblastic leukemia was significantly associated with the daily morphine dosage (P = .0178): patients in the lower risk arm received higher daily morphine dosages. Multivariate analyses revealed a significant difference between the groups' average daily scores for the previous 24 h and "right now." CONCLUSION: In this population of children with vincristine-related neuropathic pain, opioid consumption and pain scores were higher in the gabapentin group than in the placebo group. Future randomized, double-blind, placebo-controlled studies should test gabapentin given longer or at a higher dose.
RCT Entities:
BACKGROUND: To evaluate the efficacy of gabapentin at 20 mg/kg per day in the treatment of vincristine-related neuropathic pain. PROCEDURE: Children aged 1-18 years who developed vincristine-induced neuropathy on a St Jude frontline acute lymphoblastic leukemia trial were prospectively enrolled on a randomized, double-blind, placebo-controlled, phase II trial with two treatment arms: gabapentin plus opioid versus placebo plus opioid. Daily evaluations of morphine dose (mg/kg per day) and pain scores were conducted for up to 21 days; the values of the two arms were compared to assess analgesic efficacy. RESULTS: Of 51 study participants, 49 were eligible for analyses. Twenty-five participants were treated with gabapentin, with a mean (SD) dose of 17.97 (2.76) mg/kg per day (median 18.26, range 6.82-21.37). The mean (SD) opioid doses taken, expressed as morphine equivalent daily (mg/kg per day), were 0.26 (0.43) in the gabapentin group (25 patients, 432 days) and 0.15 (0.22) in the placebo group (24 patients, 411 days; P = .15). Only the risk classification of acute lymphoblastic leukemia was significantly associated with the daily morphine dosage (P = .0178): patients in the lower risk arm received higher daily morphine dosages. Multivariate analyses revealed a significant difference between the groups' average daily scores for the previous 24 h and "right now." CONCLUSION: In this population of children with vincristine-related neuropathic pain, opioid consumption and pain scores were higher in the gabapentin group than in the placebo group. Future randomized, double-blind, placebo-controlled studies should test gabapentin given longer or at a higher dose.
Authors: Shinji Kishi; Cheng Cheng; Deborah French; Deqing Pei; Soma Das; Edwin H Cook; Nobuko Hijiya; Carmelo Rizzari; Gary L Rosner; Tony Frudakis; Ching-Hon Pui; William E Evans; Mary V Relling Journal: Blood Date: 2007-01-30 Impact factor: 22.113
Authors: Joanne Wolfe; Jim F Hammel; Kelly E Edwards; Janet Duncan; Michael Comeau; Joanna Breyer; Sarah A Aldridge; Holcombe E Grier; Charles Berde; Veronica Dussel; Jane C Weeks Journal: J Clin Oncol Date: 2008-04-01 Impact factor: 44.544
Authors: Sima Jeha; Deqing Pei; John Choi; Cheng Cheng; John T Sandlund; Elaine Coustan-Smith; Dario Campana; Hiroto Inaba; Jeffrey E Rubnitz; Raul C Ribeiro; Tanja A Gruber; Susana C Raimondi; Raja B Khan; Jun J Yang; Charles G Mullighan; James R Downing; William E Evans; Mary V Relling; Ching-Hon Pui Journal: J Clin Oncol Date: 2019-10-28 Impact factor: 44.544