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

Information source: Glostrup University Hospital,Copenhagen
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain, Postoperative

Intervention: paracetamol + placebo + placebo (Drug); paracetamol + pregabalin + placebo (Drug); paracetamol + pregabalin + dexamethasone (Drug)

Phase: Phase 4

Status: Recruiting

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

Overall contact:
Ole Mathiesen, MD, PhD, Phone: +4523462485, Email: olemat@dadlnet.dk

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.

Clinical Details

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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Pain score (VAS) 2, 4, and 24 hours postoperatively.

Both at rest and when swallowing 50 ml of water.

Secondary outcome:

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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ole Mathiesen, MD, PhD, Phone: +4523462485, Email: olemat@dadlnet.dk

Department of Day Case Surgery at Glostrup University Hospital, Glostrup 2600, Denmark; Recruiting
Ole Mathiesen, MD, Phone: +45 43 23 25 14, Email: olem@glostruphosp.kbhamt.dk
Additional Information

Starting date: January 2006
Ending date: April 2010
Last updated: August 3, 2009

Page last updated: October 19, 2009

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