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

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
paracetamol + placebo + placebo
paracetamol + pregabalin + placebo
paracetamol + pregabalin + dexamethasone
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Tonsillectomy, pregabalin, dexamethasone, multimodal postoperative analgesia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Day Case Surgery at Glostrup University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Paracetamol

Paracetamol + Pregabalin

Paracetamol + pregabalin + dexamethasone

Arm Description

Oral paracetamol 1 g + placebo + placebo

Oral paracetamol 1g + oral pregabalin 300 mg + placebo

Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg

Outcomes

Primary Outcome Measures

Pain score (VAS) 2, 4, and 24 hours postoperatively.
Both at rest and when swallowing 50 ml of water.

Secondary Outcome Measures

Total amount of morphine and ketobemidone used 0-24 hours postoperatively.
Nausea and vomiting 2, 4, and 24 hours postoperatively.
Dizziness and sedation 2, 4, and 24 hours postoperatively.

Full Information

First Posted
September 19, 2006
Last Updated
December 31, 2009
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00378547
Brief Title
Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy
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 Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
ENT surgery stopped at the recruiting hospital
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Tonsillectomy, pregabalin, dexamethasone, multimodal postoperative analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Placebo Comparator
Arm Description
Oral paracetamol 1 g + placebo + placebo
Arm Title
Paracetamol + Pregabalin
Arm Type
Experimental
Arm Description
Oral paracetamol 1g + oral pregabalin 300 mg + placebo
Arm Title
Paracetamol + pregabalin + dexamethasone
Arm Type
Experimental
Arm Description
Oral paracetamol 1g + oral pregabalin 300 mg + IV dexamethasone 8 mg
Intervention Type
Drug
Intervention Name(s)
paracetamol + placebo + placebo
Other Intervention Name(s)
Acetaminophen
Intervention Description
Comparing the analgesic effect of combinations of paracetamol + placebo + placebo
Intervention Type
Drug
Intervention Name(s)
paracetamol + pregabalin + placebo
Other Intervention Name(s)
Acetaminophen, Pregabalin
Intervention Description
Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + placebo
Intervention Type
Drug
Intervention Name(s)
paracetamol + pregabalin + dexamethasone
Other Intervention Name(s)
Acetaminophen, Pregabalin, Dexamethasone
Intervention Description
Comparing the analgesic effect of combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Primary Outcome Measure Information:
Title
Pain score (VAS) 2, 4, and 24 hours postoperatively.
Time Frame
0-24 hours
Title
Both at rest and when swallowing 50 ml of water.
Time Frame
0-24 hours
Secondary Outcome Measure Information:
Title
Total amount of morphine and ketobemidone used 0-24 hours postoperatively.
Time Frame
0-24 hours
Title
Nausea and vomiting 2, 4, and 24 hours postoperatively.
Time Frame
0-24 hours
Title
Dizziness and sedation 2, 4, and 24 hours postoperatively.
Time Frame
0-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Mathiesen, MD
Organizational Affiliation
Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Day Case Surgery at Glostrup University Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

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

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