Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •5 - 18 years of age;
- •surgery: lateral thoracotomy or Ravitch procedure;
- •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.
Arms & Interventions
Gabapentin
- Single dose preoperative gabapentin.
- After surgery gabapentin 2 times per day for 3 days.
Intervention: Gabapentin (Drug)
Placebo Control
- Single dose preoperative placebo control.
- After surgery placebo 2 times per day for 3 days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time Frame: postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time Frame: postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time Frame: postoperative day: 0-3
Secondary Outcomes
- Total ropivacaine/fentanyl consumption.(postoperative day: 0-3)
- Side Effect Occurrence(first 3 days after surgery)
- Total morphine consumption.(postoperative day: 0-3)
- Patient satisfaction.(first 3 days after surgery)
- Anxiety intensity scores.(before surgery, postoperative day 3)
- The number of doses of metamizol as a "rescue drug"(postoperative day: 0-3)
Investigators
Lucyna Tomaszek, PhD, RN
Head of Nursing, Specialist Nurse in Anesthesia and Intensive Care
National Institute for Tuberculosis and Lung Diseases, Poland