NCT00378547

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

Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Tonsillectomy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Glostrup University Hospital, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	paracetamol + placebo + placebo	Comparing the analgesic effect of combinations of paracetamol + placebo + placebo
DRUG	paracetamol + pregabalin + placebo	Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo
DRUG	paracetamol + pregabalin + dexamethasone	Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-09-20
• Last updated: 2010-01-01

Locations

1 site across 1 country: Denmark