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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: paracetamol + placebo + placebo
* Drug: paracetamol + pregabalin + placebo
* Drug: paracetamol + pregabalin + dexamethasone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Paracetamol<br>Oral paracetamol 1 g + placebo + placebo | Drug: paracetamol + placebo + placebo<br>* Comparing the analgesic effect of combinations of paracetamol + placebo + placebo<br>* Other names: Acetaminophen;|
| Experimental: Paracetamol + Pregabalin<br>Oral paracetamol 1g + oral pregabalin 300 mg + placebo | Drug: paracetamol + pregabalin + placebo<br>* Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo<br>* Other names: Pregabalin;|
| Experimental: Paracetamol + pregabalin + dexamethasone<br>Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg | Drug: paracetamol + pregabalin + dexamethasone<br>* Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg<br>* Other names: Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, pregabalin, dexamethasone, multimodal postoperative analgesia