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

Purpose

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.

Condition	Intervention	Phase
Surgery	Drug: Placebo Drug: Ibuprofen 400 mg Drug: Ibuprofen Drug: Paracetamol (acetaminophen) Drug: Paracetamol (acetaminophen) + codeine	Phase IV

ChemIDplus related topics:

Ibuprofen Dexibuprofen Lactose Acetaminophen Codeine Codeine phosphate Gelatin

U.S. FDA Resources

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

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

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:

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

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 ]

Estimated Enrollment:	350
Study Start Date:	June 2007
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo Comparator	Drug: Placebo Lactose as powder in gelatine capsules, single dose
2: Active Comparator Ibuprofen 400 mg	Drug: Ibuprofen 400 mg Ibuprofen 400 mg as powder in gelatine capsules, single dose
3: Active Comparator Ibuprofen 600 mg	Drug: Ibuprofen Ibuprofen 600 mg as powder in gelatine capsules, single dose
4: Active Comparator Ibuprofen 800 mg	Drug: Ibuprofen Ibuprofen 800 mg as powder in gelatine capsules, single dose
5: Active Comparator Paracetamol 500 mg (acetaminophen)	Drug: Paracetamol (acetaminophen) Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose
6: Active Comparator Paracetamol 1000 mg (acetaminophen)	Drug: Paracetamol (acetaminophen) Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose
7: Active Comparator Paracetamol (acetaminophen) 1000 mg + codeine 60 mg	Drug: Paracetamol (acetaminophen) + codeine Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose

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.

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699114

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

Locations


Norway
	Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital	Recruiting
	Oslo, Norway, N-0407
	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
	Principal Investigator: Lasse A Skoglund, DDS, DSci
	Sub-Investigator: Gaute Lyngstad, DDS

Sponsors and Collaborators

Ullevaal University Hospital

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

More Information

Responsible Party:	University of Oslo ( Professor Lasse A. Skoglund, DDS, DSci )
Study ID Numbers:	PARIBU-020
First Received:	June 12, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00699114
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services

Keywords provided by Ullevaal University Hospital:

Pain

Analgesics

Molar

Third

Acetaminophen

Paracetamol

Ibuprofen

Codeine

Placebo

Study placed in the following topic categories:

Naphazoline

Oxymetazoline

Ibuprofen

Guaifenesin

Phenylephrine

Pain

Phenylpropanolamine

Acetaminophen

Codeine

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Molecular Mechanisms of Pharmacological Action

Cyclooxygenase Inhibitors

Physiological Effects of Drugs

Central Nervous System Depressants

Enzyme Inhibitors

Narcotics

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Antitussive Agents

Central Nervous System Agents

Analgesics, Opioid

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Ullevaal University Hospital University of Oslo
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00699114