Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain

July 3, 2011 updated by: Ullevaal University Hospital

Analgesic Effect of Ibuprofen 400, 600 and 800 mg, Paracetamol 500 and 1000 mg, and Paracetamol 1000 mg Plus 60 mg Codeine: Single-dose, Randomized, Placebo-controlled and Double-blind Study on Acute Pain After Third Molar Surgery

The purpose of this placebo controlled clinical trial is to evaluate the dose response relationship of ibuprofen in doses from 400 mg to 800 mg and paracetamol (acetaminophen)in doses from 500 mg to 1000 mg compared with paracetamol (acetaminophen)1000 mg plus codeine 60 mg on acute postoperative pain after surgical removal of impacted third molars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acetaminophen (paracetamol) and related aspirin-like drugs have traditionally been used for pain control of minor to moderate postoperative pain. Gradually traditional non-steroidal anti-inflammatory drugs (NSAIDs) have become more popular as analgesics due to assumed superior therapeutic effects and aggressive marketing campaigns orchestrated by the pharmaceutical industry.

Ibuprofen is a widely used analgesic both in non-prescription and prescription doses.

A dose-response relationship for low ibuprofen doses is shown. Evidence of a progressing dose response relationship for moderate (i.e. 400 mg) to higher doses is scarce. A possible analgesic ceiling effect has been suggested for doses above 400 mg, although a correlation between given ibuprofen doses above 400 mg and patient serum levels is shown. However, it may be questioned if the plasma concentration of ibuprofen is an important determinator of analgesic drug efficacy. A higher dose is more likely to influence the duration of analgesic effect rather than the peak analgesic effect.

There are few clinical trials investigating the dose-response relationship of increasing ibuprofen doses and paracetamol doses. To our knowledge no published study has investigated the dose-response relationship of ibuprofen and paracetamol in the same trial with a negative (i.e. placebo) and a positive (i.e. best standard analgesic treatment) control group.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, N-0407
        • Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes referred for surgical removal of impacted third molars, due to symptoms or after being advised to do so by their dentist.
  • Persons of both sexes (ASA type I).
  • Females who are not pregnant or plan conception.
  • Persons who have not used analgesics for 3 days prior to the day of surgery.
  • Persons without known active ulcus or gastrointestinal bleeding.
  • Persons without any known hypersensitivity for NSAIDs.
  • Persons under no other continuous drug treatment than contraceptives.
  • Caucasian origin.
  • Persons with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars.

Exclusion Criteria:

  • Patients with surgery time exceeding 60 minutes
  • Peroperative complications such as profuse bleeding or perforation to the maxillary sinus requiring additional drug treatment during or after the surgical removal of the third molar.
  • Postoperative complications such as extended bleeding, nausea and regurgitation during the observation period.
  • Smoking before taking the test-drug or during the observation period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Single dose placebo capsule
Drug: Placebo
Lactose as powder in gelatine capsules, single dose
Other Names:
  • Lactose
Active Comparator: Ibuprofen 400 mg
Single dose ibuprofen 400 mg capsule
Drug: Ibuprofen 400 mg
Ibuprofen 400 mg as powder in gelatine capsules, single dose
Other Names:
  • M01A E01 Ibuprofen
Active Comparator: Ibuprofen 600 mg
Single dose ibuprofen 600 mg capsule
Drug: Ibuprofen 600 mg
Ibuprofen 600 mg as powder in gelatine capsules, single dose
Other Names:
  • M01A E01 Ibuprofen
Active Comparator: Ibuprofen 800 mg
Single dose ibuprofen 800 mg capsule
Drug: Ibuprofen 800 mg
Ibuprofen 800 mg as powder in gelatine capsules, single dose
Other Names:
  • M01A E01 Ibuprofen
Active Comparator: Paracetamol 500 mg
Paracetamol 500 mg (acetaminophen) capsule
Drug: Paracetamol (acetaminophen) 500 mg
Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose
Other Names:
  • N02B E01 Paracetamol (acetaminophen)
Active Comparator: Paracetamol 1000 mg
Single dose paracetamol 1000 mg (acetaminophen) capsule
Drug: Paracetamol (acetaminophen) 1000 mg
Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose
Other Names:
  • N02B E01 Paracetamol (acetaminophen)
Active Comparator: Paracetamol 1000 mg + codeine 60 mg
Single dose paracetamol (acetaminophen) 1000 mg + codeine 60 mg capsule
Drug: Paracetamol (acetaminophen) 1000 mg + codeine 60 mg
Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose
Other Names:
  • N02B E01 Paracetamol (acetaminophen) + R05D A04 codeine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sum Pain Intensity Score(SPI)
Time Frame: 3 hour observation period
3 hour observation period

Secondary Outcome Measures

Outcome Measure
Time Frame
Sum Pain Intensity Difference Score (SPID)
Time Frame: 3 hours
3 hours
Sum Pain Intensity Score (SPI)
Time Frame: 6 hours
6 hours
Sum Pain Intensity Difference Score (SPID)
Time Frame: 6 hours
6 hours
Maximum Pain Intensity Difference Score (MAXPID)
Time Frame: Unknown, calculated variable
Unknown, calculated variable
Time to Maximum Pain Intensity Difference Score
Time Frame: Unknown, calculated variable
Unknown, calculated variable
Self-reported Occurrence of Adverse Effects
Time Frame: 3 hours
3 hours
Self-reported Occurrence of Adverse Effects
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Collaborators

University of Oslo

Investigators

  • Study Chair: Lasse A Skoglund, DDS, DSCi, Section of Dental Pharmacology and Pharmacotherapy, ICD, Faculty of Dentistry, University of Oslo, POB 1119 Blindern, N-0317 Oslo, Norway
  • Study Director: Per Skjelbred, MD, DDS, PhD, Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital, Kirkeveien 166, N-0407 Oslo, Norway
  • Principal Investigator: Gaute Lyngstad, DDS, Section of Dental Pharmacology and Pharmacotherapy, ICD, Faculty of Dentistry, University of Oslo, POB 1119 Blindern, N0317 Oslo, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARIBU-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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