The role of peri-operative gabapentin in the management of pain following tonsillectomy

The role of gabapentin in the management of pain following tonsillectomy in all patients over 16 years old, compared with placebo, with pain being the primary outcome assessed.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000663752

Enrollment

Registered

2013-06-19

Start date

2014-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to assess whether gabapentin reduces post-operative pain after tonsillectomy compared to placebo. The study's hypothesis is that gabapentin reduces post-operative pain after tonsillectomy compared to placebo.

Interventions

A single pre-operative dose of oral gabapentin 600mg (capsule) given 30 minutes prior to induction with oral paracetamol 1g (tablet).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Participants will be aged 16 years and over, scheduled for elective tonsillectomy between January 2014 and December 2014

Exclusion criteria

Exclusion criteria will include contraindications to gabapentin, other concurrent procedures, revision or unilateral tonsillectomy, inability to complete the scoring charts, and those with suspected malignancy.

Outcome results