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

Sponsored by:	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

MedlinePlus related topics: 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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	150
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Paracetamol + placebo + placebo	Drug: paracetamol + placebo + placebo Comparing the analgesic effect of combinations of paracetamol + placebo + placebo
2: Experimental Paracetamol + pregabalin + placebo	Drug: paracetamol + pregabalin + placebo Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo
3: Experimental Paracetamol + pregabalin + dexamethasone	Drug: paracetamol + pregabalin + dexamethasone Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

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

Contacts

Contact: Ole Mathiesen, MD

+45 43232514

olem@glostruphosp.kbhamt.dk

Locations

Denmark
Department of Day Case Surgery at Glostrup University Hospital	Recruiting
Glostrup, Denmark, 2600
Contact: Ole Mathiesen, MD +45 43 23 25 14 olem@glostruphosp.kbhamt.dk

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:	Dept of Anaesthesiology ( Ole Mathiesen )
Study ID Numbers:	SM4-05
Study First Received:	September 19, 2006
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00378547 History of Changes
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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pregabalin
Antiemetics
Pain
Hormones
Glucocorticoids

Signs and Symptoms
Postoperative Complications
Analgesics, Non-Narcotic
Analgesics
Peripheral Nervous System Agents
Anticonvulsants
Pain, Postoperative
Dexamethasone acetate
Acetaminophen

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Pain
Hormones
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Analgesics
Dexamethasone acetate

Acetaminophen
Pain, Postoperative
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pregabalin
Glucocorticoids
Pharmacologic Actions
Postoperative Complications
Analgesics, Non-Narcotic
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009