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

National Institute for Tuberculosis and Lung Diseases, Poland

Status and phase: Completed; Phase 4

Conditions: Surgery, Thoracic; Pain, Postoperative

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT03393702

10.11

Details and patient eligibility

About

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.

Full 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).

Enrollment: 104 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

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

Treatment:

Drug: Gabapentin

Placebo Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo