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

Pain, Postoperative Clinical Trial

Official title:

Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393702
• Other study ID #: 10.11
• Status: Completed
• Phase: Phase 4
• Start date: May 9, 2017
• Est. completion date: December 3, 2020

Study information

• Verified date: August 2021
• Source: National Institute for Tuberculosis and Lung Diseases, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 3, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgery, Thoracic

Intervention

Drug:
• Gabapentin
Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin. Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day.
• Placebo
Patients in this arm of the study receive identical placebo capsules 1 hour before surgery. Patients after surgery receive identical placebo capsules 2 times per day.

Locations

Country	Name	City	State
Poland	Institute for Tuberculosis and Lung Diseases, Pediatric Division	Rabka-Zdrój	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Tuberculosis and Lung Diseases, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)		postoperative day: 0-3
Primary	Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)		postoperative day: 0-3
Primary	Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)		postoperative day: 0-3
Secondary	Total ropivacaine/fentanyl consumption.		postoperative day: 0-3
Secondary	Total morphine consumption.		postoperative day: 0-3
Secondary	Anxiety intensity scores.	Patients rate their anxiety using State-Trait Anxiety Inventory.	before surgery, postoperative day 3
Secondary	Side Effect Occurrence	Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, urinary retention, complication in relation to administering of the drugs to epidural space.	first 3 days after surgery
Secondary	The number of doses of metamizol as a "rescue drug"		postoperative day: 0-3
Secondary	Patient satisfaction.	Responses can range from 0 (very dissatisfied) to 10 (very satisfied).	first 3 days after surgery