Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin
- Conditions
- Surgery, ThoracicPain, Postoperative
- Interventions
- Drug: Placebo
- Registration Number
- NCT03393702
- Lead Sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 5 - 18 years of age;
- surgery: lateral thoracotomy or Ravitch procedure;
- ASA 1-3;
- postoperative analgesia: thoracic epidural analgesia or intravenous infusion of morphine.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Control Placebo 1. Single dose preoperative placebo control. 2. After surgery placebo 2 times per day for 3 days. Gabapentin Gabapentin 1. Single dose preoperative gabapentin. 2. After surgery gabapentin 2 times per day for 3 days.
- Primary Outcome Measures
Name Time Method Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.) postoperative day: 0-3 Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.) postoperative day: 0-3 Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.) postoperative day: 0-3
- Secondary Outcome Measures
Name Time Method Total ropivacaine/fentanyl consumption. postoperative day: 0-3 Side Effect Occurrence 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.
Total morphine consumption. postoperative day: 0-3 Patient satisfaction. first 3 days after surgery Responses can range from 0 (very dissatisfied) to 10 (very satisfied).
Anxiety intensity scores. before surgery, postoperative day 3 Patients rate their anxiety using State-Trait Anxiety Inventory.
The number of doses of metamizol as a "rescue drug" postoperative day: 0-3
Trial Locations
- Locations (1)
Institute for Tuberculosis and Lung Diseases, Pediatric Division
🇵🇱Rabka-Zdrój, Małopolska, Poland