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

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ClinicalTrials.gov Identifier: NCT00378547
Recruitment Status : Terminated (ENT surgery stopped at the recruiting hospital)
First Posted : September 20, 2006
Last Update Posted : January 1, 2010
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: paracetamol + placebo + placebo Drug: paracetamol + pregabalin + placebo Drug: paracetamol + pregabalin + dexamethasone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Pain score (VAS) 2, 4, and 24 hours postoperatively. [ Time Frame: 0-24 hours ]
  2. Both at rest and when swallowing 50 ml of water. [ Time Frame: 0-24 hours ]

Secondary Outcome Measures :
  1. Total amount of morphine and ketobemidone used 0-24 hours postoperatively. [ Time Frame: 0-24 hours ]
  2. Nausea and vomiting 2, 4, and 24 hours postoperatively. [ Time Frame: 0-24 hours ]
  3. Dizziness and sedation 2, 4, and 24 hours postoperatively. [ Time Frame: 0-24 hours ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: January 1, 2010
Last Verified: December 2009

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Acetaminophen
Pregabalin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Analgesics
Sensory System Agents
Antipyretics