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

Glostrup University Hospital, Copenhagen

Status and phase: Terminated; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: paracetamol + placebo + placebo; Drug: paracetamol + pregabalin + placebo; Drug: paracetamol + pregabalin + dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00378547

SM4-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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147 participants in 3 patient groups, including a placebo group

Paracetamol

Placebo Comparator group

Description:

Oral paracetamol 1 g + placebo + placebo

Treatment:

Drug: paracetamol + placebo + placebo

Paracetamol + Pregabalin

Experimental group

Description:

Oral paracetamol 1g + oral pregabalin 300 mg + placebo

Treatment:

Drug: paracetamol + pregabalin + placebo

Paracetamol + pregabalin + dexamethasone

Experimental group

Description:

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

Treatment:

Drug: paracetamol + pregabalin + dexamethasone