Clinical trial NCT03393702: Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin
Official title: Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Surgery, Thoracic
Keywords: Postoperative pain
Anxiety
Postoperative Complications
Patient Satisfaction
Lead sponsor: National Institute for Tuberculosis and Lung Diseases, Poland
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 104
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The subjects are randomized to the Gabapentin or Placebo group. All patients receive preoperative gabapentin (15 mg/kg, treatment) or placebo, respectively and after surgery either gabapentin (7,5 mg/kg, treatment) or placebo 2 times per day for 3 days, respectively.

Patients are subjected to the same anaesthesia protocol. Postoperative analgesia are achieved with either continuous ropivacaine 0.2%/fentanyl 5.0 μg/ml infusion through a thoracic epidural catheter (N=40; Gabapentin n=20, Placebo n=20), or intravenous infusion of morphine (N=40; Gabapentin n=20, Placebo n=20). All patients receive acetaminophen and non-steroidal anti-inflammatory drugs, and metamizol as a "rescue drug"

The intravenous infusion of morphine grup was expanded on the basis of the bioethics commission's decision KB-125/2019 (N=64; Gabapentin n=32, Placebo n=32).

Eligibility criteria: Inclusion Criteria:

* 5 - 18 years of age;
* surgery: lateral thoracotomy or Ravitch procedure;
* ASA 1-3;
* postoperative analgesia: thoracic epidural analgesia or intravenous infusion of morphine.

Exclusion Criteria:

* allergy or sensitivity to gabapentin;
* history of chronic pain or daily analgesic use;
* diagnosed with psychiatric disorders;
* treated oncologically;
* with impaired verbal communication;
* the lack of postoperative chest drainage.

Primary outcomes:
measure: Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
timeFrame: postoperative day: 0-3
measure: Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
timeFrame: postoperative day: 0-3
measure: Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
timeFrame: postoperative day: 0-3
Secondary outcomes:
measure: Total ropivacaine/fentanyl consumption.
timeFrame: postoperative day: 0-3
measure: Total morphine consumption.
timeFrame: postoperative day: 0-3
measure: Anxiety intensity scores.
timeFrame: before surgery, postoperative day 3
measure: Side Effect Occurrence
timeFrame: first 3 days after surgery
measure: The number of doses of metamizol as a "rescue drug"
timeFrame: postoperative day: 0-3
measure: Patient satisfaction.
timeFrame: first 3 days after surgery
Other outcomes:
Locations:
city: Rabka-Zdrój
country: Poland
facility: Institute for Tuberculosis and Lung Diseases, Pediatric Division
state: Małopolska
Study officials:
affiliation: National Institute for Tuberculosis and Lung Diseases, Poland
name: Lucyna Tomaszek, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.