drugset / Trial / NCT03275012
Efficacy and Safety Study of Gabapentin as add-on to Morphine in Paediatric Patients Affected by Chronic Pain
RandomizedParallel-groupTriple-blindTreatment
Summary
The objective of the study is to evaluate the efficacy of gabapentin as adjunctive therapy to morphine in the treatment of severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age assessed by the difference in average pain scores between treatment arms at the end of the treatment period.
Timeline
- Start
- 2017-04-04
- Primary completion
- 2019-10-21
- Completion
- 2019-10-21
Publications
- Background Finnerup NB, Sindrup SH, Jensen TS. Recent advances in pharmacological treatment of neuropathic pain. F1000 Med Rep. 2010 Jul 14;2:52. doi: 10.3410/M2-52.
- Background Mellegers MA, Furlan AD, Mailis A. Gabapentin for neuropathic pain: systematic review of controlled and uncontrolled literature. Clin J Pain. 2001 Dec;17(4):284-95. doi: 10.1097/00002508-200112000-00002.
- de Leeuw TG, Mangiarini L, Lundin R, Kaguelidou F, van der Zanden T, Pasqua OD, Tibboel D, Ceci A, de Wildt SN; GAPP consortium. 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. 2019 Jan 15;20(1):49. doi: 10.1186/s13063-018-3169-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 45 mg/kg | Oral |
| Subject | Gabapentin | Small molecule | 63 mg/kg | Oral |
| Background | Morphine | Other / unclassified | 1.2 mg/kg | Oral |