Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin

NCT03393702 | Completed Phase 4 DMC

• 1 other identifier: 10.11
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Surgery, Thoracic

Keywords

Postoperative pain; Anxiety; Postoperative Complications; Patient Satisfaction

Outcome Measures

Primary Outcomes (3)

• Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)

  postoperative day: 0-3

• Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)

  postoperative day: 0-3

• Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)

  postoperative day: 0-3

Secondary Outcomes (6)

• Total ropivacaine/fentanyl consumption.

  postoperative day: 0-3

• Total morphine consumption.

  postoperative day: 0-3

• Anxiety intensity scores.

  before surgery, postoperative day 3

• Side Effect Occurrence

  first 3 days after surgery

• The number of doses of metamizol as a "rescue drug"

  postoperative day: 0-3

Study Arms (2)

Gabapentin

EXPERIMENTAL

1. Single dose preoperative gabapentin. 2. After surgery gabapentin 2 times per day for 3 days.

Drug: Gabapentin

Placebo Control

PLACEBO COMPARATOR

1. Single dose preoperative placebo control. 2. After surgery placebo 2 times per day for 3 days.

Drug: Placebo

Interventions

Gabapentin DRUG

1. Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin. 2. Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day.

Also known as: Gabapentin TEVA, capsules

Gabapentin

Placebo DRUG

1. Patients in this arm of the study receive identical placebo capsules 1 hour before surgery. 2. Patients after surgery receive identical placebo capsules 2 times per day.

Placebo Control

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute for Tuberculosis and Lung Diseases, Poland: lead

Study Sites (1)

Institute for Tuberculosis and Lung Diseases, Pediatric Division

Rabka-Zdrój, Małopolska, 34-700, Poland

Location

Related Publications (4)

• 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.

  PMID: 20418301 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.

  PMID: 25230144 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.

  PMID: 31596461 BACKGROUND

• 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.

  PMID: 36554581 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Postoperative Complications; Patient Satisfaction

Interventions

Gabapentin; Capsules

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Lucyna Tomaszek, PhD

  National Institute for Tuberculosis and Lung Diseases, Poland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nursing, Specialist Nurse in Anesthesia and Intensive Care

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 8, 2018
• Study Start: May 9, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 3, 2020
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

PL (1)