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

Sponsor:	Glostrup University Hospital, Copenhagen
Information provided by:	Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:	NCT00378547

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 IV

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:

MedlinePlus related topics: Dizziness and Vertigo Nausea and Vomiting Tonsils and Adenoids

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Acetaminophen Pregabalin CT 2584 Dexamethasone Sodium Phosphate

U.S. FDA Resources

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

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
Acetaminophen
Pregabalin
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Analgesics, Opioid
Gamma-Aminobutyric Acid
Antipyretics
Physiological Effects of Drugs

Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on February 09, 2012