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

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00699114
First received: June 12, 2008
Last updated: July 3, 2011
Last verified: February 2009

June 12, 2008
July 3, 2011
June 2007
December 2009   (final data collection date for primary outcome measure)
Sum Pain Intensity Score(SPI) [ Time Frame: 3 hour observation period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00699114 on ClinicalTrials.gov Archive Site
  • Sum Pain Intensity Difference Score (SPID) [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • Sum Pain Intensity Score (SPI) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Sum Pain Intensity Difference Score (SPID) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Maximum Pain Intensity Difference Score (MAXPID) [ Time Frame: Unknown, calculated variable ] [ Designated as safety issue: No ]
  • Time to Maximum Pain Intensity Difference Score [ Time Frame: Unknown, calculated variable ] [ Designated as safety issue: No ]
  • Self-reported Occurrence of Adverse Effects [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
  • Self-reported Occurrence of Adverse Effects [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Surgery
  • Drug: Placebo
    Lactose as powder in gelatine capsules, single dose
    Other Name: Lactose
  • Drug: Ibuprofen 400 mg
    Ibuprofen 400 mg as powder in gelatine capsules, single dose
    Other Name: M01A E01 Ibuprofen
  • Drug: Ibuprofen 600 mg
    Ibuprofen 600 mg as powder in gelatine capsules, single dose
    Other Name: M01A E01 Ibuprofen
  • Drug: Ibuprofen 800 mg
    Ibuprofen 800 mg as powder in gelatine capsules, single dose
    Other Name: M01A E01 Ibuprofen
  • Drug: Paracetamol (acetaminophen) 500 mg
    Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose
    Other Name: N02B E01 Paracetamol (acetaminophen)
  • Drug: Paracetamol (acetaminophen) 1000 mg
    Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose
    Other Name: N02B E01 Paracetamol (acetaminophen)
  • Drug: Paracetamol (acetaminophen) 1000 mg + codeine 60 mg
    Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose
    Other Name: N02B E01 Paracetamol (acetaminophen) + R05D A04 codeine
  • Placebo Comparator: Placebo
    Single dose placebo capsule
    Intervention: Drug: Placebo
  • Active Comparator: Ibuprofen 400 mg
    Single dose ibuprofen 400 mg capsule
    Intervention: Drug: Ibuprofen 400 mg
  • Active Comparator: Ibuprofen 600 mg
    Single dose ibuprofen 600 mg capsule
    Intervention: Drug: Ibuprofen 600 mg
  • Active Comparator: Ibuprofen 800 mg
    Single dose ibuprofen 800 mg capsule
    Intervention: Drug: Ibuprofen 800 mg
  • Active Comparator: Paracetamol 500 mg
    Paracetamol 500 mg (acetaminophen) capsule
    Intervention: Drug: Paracetamol (acetaminophen) 500 mg
  • Active Comparator: Paracetamol 1000 mg
    Single dose paracetamol 1000 mg (acetaminophen) capsule
    Intervention: Drug: Paracetamol (acetaminophen) 1000 mg
  • Active Comparator: Paracetamol 1000 mg + codeine 60 mg
    Single dose paracetamol (acetaminophen) 1000 mg + codeine 60 mg capsule
    Intervention: Drug: Paracetamol (acetaminophen) 1000 mg + codeine 60 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00699114
PARIBU-020
No
Professor Lasse A. Skoglund, DDS, DSci, University of Oslo
Ullevaal University Hospital
University of Oslo
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
Oslo University Hospital
February 2009

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