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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2020-12-03

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pain, Postoperative Surgery, Thoracic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gabapentin

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

Group Type EXPERIMENTAL

Gabapentin

Intervention Type 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.

Placebo Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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Gabapentin

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Other Intervention Names

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Gabapentin TEVA, capsules

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No