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

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Tracking Information

First Received Date ^†

June 12, 2008

Last Updated Date

June 16, 2008

Start Date ^†

June 2007

Current Primary Outcome Measures ^†

Sum Pain Intensity Score(SPI) [ Time Frame: 3 hour observation period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00699114 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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.

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 Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Surgery

Intervention ^†

Drug: Placebo
Drug: Ibuprofen 400 mg
Drug: Ibuprofen
Drug: Paracetamol (acetaminophen)
Drug: Paracetamol (acetaminophen) + codeine

Study Arms / Comparison Groups

Placebo Comparator: Placebo Comparator
Active Comparator: Ibuprofen 400 mg
Active Comparator: Ibuprofen 600 mg
Active Comparator: Ibuprofen 800 mg
Active Comparator: Paracetamol 500 mg (acetaminophen)
Active Comparator: Paracetamol 1000 mg (acetaminophen)
Active Comparator: Paracetamol (acetaminophen) 1000 mg + codeine 60 mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

350

Estimated Completion Date

January 2011

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years to 30 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Lasse A Skoglund, DDS, DSci	0047 228 44 672	lasses@odont.uio.no
Contact: Gaute Lyngstad, DDS	0047 228 44 673	gautelyn@odont.uio.no

Location Countries ^†

Norway

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00699114

Responsible Party

Professor Lasse A. Skoglund, DDS, DSci, University of Oslo

Secondary IDs ^††

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

Information Provided By

Ullevaal University Hospital

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.