drugset / Trial / NCT03393702
Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study is performed in patients aged 5-18 years after thoracic surgery. The primary aim of this trial is to determine whether the use of gabapentin as a component of multimodal analgesic regiments reduces pain scores following thoracic surgery in pediatric patients. The secondary objective of the trial are to evaluate whether the use of gabapentin reduces postoperative anxiety scores and consumption of ropivacaine with fentanyl, decreases side-effects, and improves patient satisfaction.
Timeline
- Start
- 2017-05-09
- Primary completion
- 2019-12-30
- Completion
- 2020-12-03
Publications
- Background Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
- Background Mayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17.
- Background Tomaszek L, Fenikowski D, Maciejewski P, Komotajtys H, Gawron D. Perioperative Gabapentin in Pediatric Thoracic Surgery Patients-Randomized, Placebo-Controlled, Phase 4 Trial. Pain Med. 2020 Aug 1;21(8):1562-1571. doi: 10.1093/pm/pnz207.
- Fenikowski D, Tomaszek L. Factors Related to Anxiety in Paediatric Patients and Their Parents before and after a Modified Ravitch Procedure-A Single-Centre Cohort Study. Int J Environ Res Public Health. 2022 Dec 12;19(24):16701. doi: 10.3390/ijerph192416701.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 7.5 mg/kg | Oral |