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

Sponsor

Glostrup University Hospital, Copenhagen (Other)

Overall Status

Terminated

CT.gov ID

NCT00378547

Collaborator

(none)

147

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: paracetamol + placebo + placebo Drug: paracetamol + pregabalin + placebo Drug: paracetamol + pregabalin + dexamethasone	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Paracetamol Oral paracetamol 1 g + placebo + placebo	Drug: paracetamol + placebo + placebo Comparing the analgesic effect of combinations of paracetamol + placebo + placebo Other Names: Acetaminophen
Experimental: Paracetamol + Pregabalin Oral paracetamol 1g + oral pregabalin 300 mg + placebo	Drug: paracetamol + pregabalin + placebo Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo Other Names: Acetaminophen Pregabalin
Experimental: Paracetamol + pregabalin + dexamethasone Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg	Drug: paracetamol + pregabalin + dexamethasone Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg Other Names: Acetaminophen Pregabalin Dexamethasone

Arm

Intervention/Treatment

Placebo Comparator: Paracetamol

Oral paracetamol 1 g + placebo + placebo

Drug: paracetamol + placebo + placebo

Comparing the analgesic effect of combinations of paracetamol + placebo + placebo

Other Names:

Acetaminophen

Experimental: Paracetamol + Pregabalin

Oral paracetamol 1g + oral pregabalin 300 mg + placebo

Drug: paracetamol + pregabalin + placebo

Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo

Other Names:

Acetaminophen

Pregabalin

Experimental: Paracetamol + pregabalin + dexamethasone

Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg

Drug: paracetamol + pregabalin + dexamethasone

Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Other Names:

Acetaminophen

Pregabalin

Dexamethasone

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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