Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy

Phase 4

Terminated

• Conditions: Pain, Postoperative
• Interventions: Drug: paracetamol + placebo + placebo; Drug: paracetamol + pregabalin + placebo; Drug: paracetamol + pregabalin + dexamethasone

• Registration Number: NCT00378547
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.

Detailed Description

We will investigate the effect of paracetamol versus paracetamol combined with pregabalin versus paracetamol combined with pregabalin and dexamethasone on pain and morphine requirements in the first 24 hours postoperatively. Outcomes include amount of morphine and ketobemidone used, and pain measured on a VAS scale. Side-effects, e.g., PONV, dizziness and sedation are also measured.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-09-19
• Study First Submitted QC: 2006-09-19
• Study First Posted: 2006-09-20
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-31
• Last Update Posted: 2010-01-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Patients scheduled for benign tonsillectomy
• Between the ages of 18 and 50 years old
• ASA 1-2 and a surgical technique without the need for local anaesthetics or electrical scissors

Exclusion Criteria

• Malignancy
• Patients who are unable to cooperate
• Does not speak Danish
• Has allergy for drugs used in the trial
• Has abused drugs and/or medicine
• Epilepsy
• Diabetes treated with medicine
• Treatment with systemic steroids 4 weeks prior to the operation
• Daily use of antacids
• Daily use of analgesics
• Use of antidepressives
• Known kidney disease
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracetamol	paracetamol + placebo + placebo	Oral paracetamol 1 g + placebo + placebo
Paracetamol + Pregabalin	paracetamol + pregabalin + placebo	Oral paracetamol 1g + oral pregabalin 300 mg + placebo
Paracetamol + pregabalin + dexamethasone	paracetamol + pregabalin + dexamethasone	Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg

Primary Outcome Measures

Name	Time	Method
Pain score (VAS) 2, 4, and 24 hours postoperatively.	0-24 hours
Both at rest and when swallowing 50 ml of water.	0-24 hours

Secondary Outcome Measures

Name	Time	Method
Total amount of morphine and ketobemidone used 0-24 hours postoperatively.	0-24 hours
Nausea and vomiting 2, 4, and 24 hours postoperatively.	0-24 hours
Dizziness and sedation 2, 4, and 24 hours postoperatively.	0-24 hours

Trial Locations

Locations (1)

Department of Day Case Surgery at Glostrup University Hospital; 🇩🇰 Glostrup, Denmark