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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paracetamol

Oral paracetamol 1 g + placebo + placebo

Group Type PLACEBO_COMPARATOR

paracetamol + placebo + placebo

Intervention Type DRUG

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

Paracetamol + Pregabalin

Oral paracetamol 1g + oral pregabalin 300 mg + placebo

Group Type EXPERIMENTAL

paracetamol + pregabalin + placebo

Intervention Type DRUG

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

Paracetamol + pregabalin + dexamethasone

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

Group Type EXPERIMENTAL

paracetamol + pregabalin + dexamethasone

Intervention Type DRUG

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

Interventions

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paracetamol + placebo + placebo

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

Intervention Type DRUG

paracetamol + pregabalin + placebo

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

Intervention Type DRUG

paracetamol + pregabalin + dexamethasone

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

Intervention Type DRUG

Other Intervention Names

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Acetaminophen Acetaminophen Pregabalin Acetaminophen Pregabalin Dexamethasone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No