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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00378547

Enrollment

147

Registered

2006-09-20

Start date

2006-01-31

Completion date

2009-12-31

Last updated

2010-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Tonsillectomy, pregabalin, dexamethasone, multimodal postoperative analgesia

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.

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.

Interventions

DRUGparacetamol + placebo + placebo

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

DRUGparacetamol + pregabalin + placebo

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

DRUGparacetamol + pregabalin + dexamethasone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026