De Leeuw, TG; Mangiarini, L; Lundin, R; Kaguelidou, F; Van der Zanden, T; Della Pasqua, O; Tibboel, D; ... GAPP consortium; + view all De Leeuw, TG; Mangiarini, L; Lundin, R; Kaguelidou, F; Van der Zanden, T; Della Pasqua, O; Tibboel, D; Ceci, A; De Wildt, SN; GAPP consortium; - view fewer (2019) Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial. Trials , 20 , Article 49. 10.1186/s13063-018-3169-3.

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Abstract

BACKGROUND: Gabapentin has shown efficacy in the treatment of chronic neuropathic or mixed pain in adults. Although pediatric pain specialists have extensive experience with gabapentin for the treatment of neuropathic pain, its use is off-label. Its efficacy and safety in this context has never been shown. The aim of this trial is to compare gabapentin versus placebo as add-on to morphine for the treatment of severe chronic mixed or neuropathic pain in children. This trial is part of EU FP7 project GAPP to develop a pediatric use marketing authorization (PUMA) for a new gabapentin suspension. METHODS: The GAPP-2 study is a randomized, double-blind placebo controlled, multicenter superiority phase II study in children with severe chronic neuropathic or mixed pain with the primary objective to evaluate the efficacy of gabapentin liquid formulation as adjunctive therapy to morphine. Sixty-six eligible children 3 months to 18 years of age with severe pain (pain scores ≥7), stratified in 3 age-groups will be randomized to receive gabapentin (to an accumulating dose of 45 to 63 mg/kg/day dependent on age) or placebo, both in addition to morphine, for 12 weeks. Randomization will be preceded by a short wash-out period and treatment will be initiated by a titration period of 3 weeks. After the treatment period, medication will be tapered during 4 weeks. The primary endpoint is the average pain scores in the two treatment groups (average of 2 measures each day for 3 days before end of study visit (V10) assessed by age-appropriate pain scales (FLACC, FPS-R, NRS-11). Secondary outcomes include: percentage responders to treatment (subjects with 30% reduction in pain scale), number of episodes of breakthrough pain, number of rescue interventions, number of pain-free days, participant dropouts, quality of life (PedsQL) and acceptability of treatment. Outcomes will be measured at the end of study visit after 12 weeks of treatment at the optimal gabapentin dose. Groups will be compared based on intention to treat DISCUSSION: We hope to provide evidence that the combination of morphine and gabapentin will provide better analgesia then morphine alone and will be safe. We also aim this study to obtain confirmation of recommended pediatric dose.

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