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

NCT00378547 | Terminated Phase 4 DMC

• 1 other identifier: SM4-05
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Tonsillectomy; pregabalin; dexamethasone; multimodal postoperative analgesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (3)

Paracetamol

PLACEBO COMPARATOR

Oral paracetamol 1 g + placebo + placebo

Drug: paracetamol + placebo + placebo

Paracetamol + Pregabalin

EXPERIMENTAL

Oral paracetamol 1g + oral pregabalin 300 mg + placebo

Drug: paracetamol + pregabalin + placebo

Paracetamol + pregabalin + dexamethasone

EXPERIMENTAL

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

Drug: paracetamol + pregabalin + dexamethasone

Interventions

paracetamol + placebo + placebo DRUG

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

Also known as: Acetaminophen

Paracetamol

paracetamol + pregabalin + placebo DRUG

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

Also known as: Acetaminophen, Pregabalin

Paracetamol + Pregabalin

paracetamol + pregabalin + dexamethasone DRUG

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

Also known as: Acetaminophen, Pregabalin, Dexamethasone

Paracetamol + pregabalin + dexamethasone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Department of Day Case Surgery at Glostrup University Hospital

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Pregabalin; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ole Mathiesen, MD

  Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 20, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 1, 2010

Record last verified: 2009-12

Locations

DK (1)