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

• ClinicalTrials.gov Identifier: NCT03393702
• Recruitment Status: Completed
• First Posted: January 8, 2018
• Last Update Posted: September 8, 2021
• Sponsor: National Institute for Tuberculosis and Lung Diseases, Poland
• Information provided by (Responsible Party): Lucyna Tomaszek, PhD, RN, National Institute for Tuberculosis and Lung Diseases, Poland

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative; Surgery, Thoracic	Drug: Gabapentin; Drug: Placebo	Phase 4

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study
• Actual Study Start Date: May 9, 2017
• Actual Primary Completion Date: December 30, 2019
• Actual Study Completion Date: December 3, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Gabapentin; Single dose preoperative gabapentin.; After surgery gabapentin 2 times per day for 3 days.	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.; Other Name: Gabapentin TEVA, capsules
Placebo Comparator: Placebo Control; Single dose preoperative placebo control.; After surgery placebo 2 times per day for 3 days.	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.) [ Time Frame: postoperative day: 0-3 ]
2. Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.) [ Time Frame: postoperative day: 0-3 ]
3. Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.) [ Time Frame: postoperative day: 0-3 ]

Secondary Outcome Measures :

1. Total ropivacaine/fentanyl consumption. [ Time Frame: postoperative day: 0-3 ]
2. Total morphine consumption. [ Time Frame: postoperative day: 0-3 ]
3. Anxiety intensity scores. [ Time Frame: before surgery, postoperative day 3 ]
   Patients rate their anxiety using State-Trait Anxiety Inventory.
4. Side Effect Occurrence [ Time Frame: first 3 days after surgery ]
   Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, urinary retention, complication in relation to administering of the drugs to epidural space.
5. The number of doses of metamizol as a "rescue drug" [ Time Frame: postoperative day: 0-3 ]
6. Patient satisfaction. [ Time Frame: first 3 days after surgery ]
   Responses can range from 0 (very dissatisfied) to 10 (very satisfied).

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Poland

Institute for Tuberculosis and Lung Diseases, Pediatric Division

Rabka-Zdrój, Małopolska, Poland, 34-700

Sponsors and Collaborators

National Institute for Tuberculosis and Lung Diseases, Poland

Investigators

• Study Director: Lucyna Tomaszek, PhD; National Institute for Tuberculosis and Lung Diseases, Poland

More Information

Publications:

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.

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.

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.

• Responsible Party: Lucyna Tomaszek, PhD, RN, Head of Nursing, Specialist Nurse in Anesthesia and Intensive Care, National Institute for Tuberculosis and Lung Diseases, Poland
• ClinicalTrials.gov Identifier: NCT03393702
• Other Study ID Numbers: 10.11
• First Posted: January 8, 2018
• Last Update Posted: September 8, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lucyna Tomaszek, PhD, RN, National Institute for Tuberculosis and Lung Diseases, Poland:

Postoperative pain; Anxiety; Postoperative Complications; Patient Satisfaction

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Gabapentin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimanic Agents