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

This study has been terminated.
(ENT surgery stopped at the recruiting hospital)
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00378547
First received: September 19, 2006
Last updated: December 31, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Drug: paracetamol + placebo + placebo
Drug: paracetamol + pregabalin + placebo
Drug: paracetamol + pregabalin + dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Pain score (VAS) 2, 4, and 24 hours postoperatively. [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
  • Both at rest and when swallowing 50 ml of water. [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total amount of morphine and ketobemidone used 0-24 hours postoperatively. [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
  • Nausea and vomiting 2, 4, and 24 hours postoperatively. [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
  • Dizziness and sedation 2, 4, and 24 hours postoperatively. [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Paracetamol
Oral paracetamol 1 g + placebo + placebo
Drug: paracetamol + placebo + placebo
Comparing the analgesic effect of combinations of paracetamol + placebo + placebo
Other Name: Acetaminophen
Experimental: Paracetamol + Pregabalin
Oral paracetamol 1g + oral pregabalin 300 mg + placebo
Drug: paracetamol + pregabalin + placebo
Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo
Other Names:
  • Acetaminophen
  • Pregabalin
Experimental: Paracetamol + pregabalin + dexamethasone
Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg
Drug: paracetamol + pregabalin + dexamethasone
Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Other Names:
  • Acetaminophen
  • Pregabalin
  • Dexamethasone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378547

Locations
Denmark
Department of Day Case Surgery at Glostrup University Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Study Chair: Ole Mathiesen, MD Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
  More Information

No publications provided

Responsible Party: Ole Mathiesen, Section of Acute Pain Management and Palliative Care
ClinicalTrials.gov Identifier: NCT00378547     History of Changes
Other Study ID Numbers: SM4-05
Study First Received: September 19, 2006
Last Updated: December 31, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
Tonsillectomy
pregabalin
dexamethasone
multimodal postoperative analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Acetaminophen
Pregabalin
BB 1101
Gamma-Aminobutyric Acid
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on September 18, 2014