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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

Tracking Information
First Submitted Date  ICMJE September 19, 2006
First Posted Date  ICMJE September 20, 2006
Last Update Posted Date January 1, 2010
Study Start Date  ICMJE January 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2008)
  • Pain score (VAS) 2, 4, and 24 hours postoperatively. [ Time Frame: 0-24 hours ]
  • Both at rest and when swallowing 50 ml of water. [ Time Frame: 0-24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
  • Pain score (VAS) 2, 4 and 24 hours postoperatively.
  • Both at rest and when swallowing 50 ml of water.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2008)
  • Total amount of morphine and ketobemidone used 0-24 hours postoperatively. [ Time Frame: 0-24 hours ]
  • Nausea and vomiting 2, 4, and 24 hours postoperatively. [ Time Frame: 0-24 hours ]
  • Dizziness and sedation 2, 4, and 24 hours postoperatively. [ Time Frame: 0-24 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
  • Total amount of morphine and ketobemidone used 0-24 h postoperatively.
  • Nausea and vomiting 2, 4 and 24 hours postoperatively.
  • Dizziness and sedation 2, 4 24 hours postoperatively.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: paracetamol + placebo + placebo
    Comparing the analgesic effect of combinations of paracetamol + placebo + placebo
    Other Name: Acetaminophen
  • Drug: paracetamol + pregabalin + placebo
    Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo
    Other Names:
    • Acetaminophen
    • Pregabalin
  • Drug: paracetamol + pregabalin + dexamethasone
    Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
    Other Names:
    • Acetaminophen
    • Pregabalin
    • Dexamethasone
Study Arms  ICMJE
  • Placebo Comparator: Paracetamol
    Oral paracetamol 1 g + placebo + placebo
    Intervention: Drug: paracetamol + placebo + placebo
  • Experimental: Paracetamol + Pregabalin
    Oral paracetamol 1g + oral pregabalin 300 mg + placebo
    Intervention: Drug: paracetamol + pregabalin + placebo
  • Experimental: Paracetamol + pregabalin + dexamethasone
    Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg
    Intervention: Drug: paracetamol + pregabalin + dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 31, 2009)
147
Original Enrollment  ICMJE
 (submitted: September 19, 2006)
150
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00378547
Other Study ID Numbers  ICMJE SM4-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ole Mathiesen, Section of Acute Pain Management and Palliative Care
Study Sponsor  ICMJE Glostrup University Hospital, Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ole Mathiesen, MD Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
PRS Account Glostrup University Hospital, Copenhagen
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP