Does gabapentin decrease the incidence of postoperative pain in children undergoing tonsillectomy procedures?

Phase 4

Recruiting

• Conditions: Pain following tonsillectomy surgery; Anaesthesiology - Pain management; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000396921
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-23
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Children aged 4-16 years
Undergoing elective surgery under general anaesthetic for tonsillectomy +/- adenoidectomy +/- grommets or cautery inferior turbinates
Staying overnight in hospital

Exclusion Criteria

•Severe obstructive sleep apnoea documented on a sleep study
•Cardiovascular, respiratory or neurological disease giving an ASA III or above status
•Known renal impairment
•Regular preoperative use of anticonvulsants, analgesics or any concomitant use of central nervous system depressants
•Known hypersensitivity to the active substance or to any of the excipients listed
•Patients will be excluded if language barriers impede data collection or if the Department for Child Protection and Family Support is involved in their care
•Patients will be excluded if they have planned admissions to the Paediatric Intensive Care Unit (PICU)
•Current or previous mental health concerns

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be self-reported pain intensity using the Faces Pain Scale -revised (FPS-R) assessed 4 times daily for 7 days. Patients will be asked to rate pain intensity twice in the morning and twice in the evening. At each time point they will be asked first to rate pain just before the meal (pain at rest) and then rate again with eating (pain on swallowing). [ Pain scores will be assessed 4 times a day for 7 days.<br>The pain intensity score for each of the 4 daily time points will be compared between groups over time i.e. morning at rest gabapentin vs placebo, morning with swallowing gabapentin vs placebo, evening at rest gabapentin vs placebo, evening with swallowing gabapentin vs placebo. Pain intensity scores will be collected across the days and compared between the 2 groups.]