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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00378547
• Other study ID #: SM4-05
• Status: Terminated
• Phase: Phase 4
• First received: September 19, 2006
• Last updated: December 31, 2009
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 147
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• paracetamol + placebo + placebo
Comparing the analgesic effect of combinations of paracetamol + placebo + placebo
• paracetamol + pregabalin + placebo
Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo
• paracetamol + pregabalin + dexamethasone
Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Locations

Country	Name	City	State
Denmark	Department of Day Case Surgery at Glostrup University Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score (VAS) 2, 4, and 24 hours postoperatively.		0-24 hours	No
Primary	Both at rest and when swallowing 50 ml of water.		0-24 hours	No
Secondary	Total amount of morphine and ketobemidone used 0-24 hours postoperatively.		0-24 hours	No
Secondary	Nausea and vomiting 2, 4, and 24 hours postoperatively.		0-24 hours	No
Secondary	Dizziness and sedation 2, 4, and 24 hours postoperatively.		0-24 hours	No