Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy
Information source: Glostrup University Hospital, Copenhagen
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Condition(s) targeted: Pain, Postoperative
Intervention: paracetamol + placebo + placebo (Drug); paracetamol + pregabalin + placebo (Drug); paracetamol + pregabalin + dexamethasone (Drug)
Phase: Phase 4
Sponsored by: Glostrup University Hospital, Copenhagen
Official(s) and/or principal investigator(s):
Ole Mathiesen, MD, Study Chair, Affiliation: Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
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
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Pain score (VAS) 2, 4, and 24 hours postoperatively.
Both at rest and when swallowing 50 ml of water.
Total amount of morphine and ketobemidone used 0-24 hours postoperatively.
Nausea and vomiting 2, 4, and 24 hours postoperatively.
Dizziness and sedation 2, 4, and 24 hours postoperatively.
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.
Minimum age: 18 Years.
Maximum age: 50 Years.
- 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
- Patients who are unable to cooperate
- Does not speak Danish
- Has allergy for drugs used in the trial
- Has abused drugs and/or medicine
- 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
Locations and Contacts
Department of Day Case Surgery at Glostrup University Hospital, Glostrup 2600, Denmark
Starting date: January 2006
Last updated: December 31, 2009