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
1 other identifier
interventional
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 surgery
Started Jun 2007
Typical duration for phase_4 surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 12, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJuly 6, 2011
February 1, 2009
2.5 years
June 12, 2008
July 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sum Pain Intensity Score(SPI)
3 hour observation period
Secondary Outcomes (7)
Sum Pain Intensity Difference Score (SPID)
3 hours
Sum Pain Intensity Score (SPI)
6 hours
Sum Pain Intensity Difference Score (SPID)
6 hours
Maximum Pain Intensity Difference Score (MAXPID)
Unknown, calculated variable
Time to Maximum Pain Intensity Difference Score
Unknown, calculated variable
- +2 more secondary outcomes
Study Arms (7)
Placebo
PLACEBO COMPARATORSingle dose placebo capsule
Ibuprofen 400 mg
ACTIVE COMPARATORSingle dose ibuprofen 400 mg capsule
Ibuprofen 600 mg
ACTIVE COMPARATORSingle dose ibuprofen 600 mg capsule
Ibuprofen 800 mg
ACTIVE COMPARATORSingle dose ibuprofen 800 mg capsule
Paracetamol 500 mg
ACTIVE COMPARATORParacetamol 500 mg (acetaminophen) capsule
Paracetamol 1000 mg
ACTIVE COMPARATORSingle dose paracetamol 1000 mg (acetaminophen) capsule
Paracetamol 1000 mg + codeine 60 mg
ACTIVE COMPARATORSingle dose paracetamol (acetaminophen) 1000 mg + codeine 60 mg capsule
Interventions
Ibuprofen 400 mg as powder in gelatine capsules, single dose
Ibuprofen 600 mg as powder in gelatine capsules, single dose
Ibuprofen 800 mg as powder in gelatine capsules, single dose
Paracetamol (acetaminophen) 500 mg as powder in gelatine capsules, single dose
Paracetamol (acetaminophen) 1000 mg as powder in gelatine capsules, single dose
Paracetamol (acetaminophen) 1000 mg + codeine 60 mg as powder in gelatine capsules, single dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ullevaal University Hospitallead
- University of Oslocollaborator
Study Sites (1)
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Oslo, N-0407, Norway
Related Publications (1)
Lyngstad G, Skjelbred P, Swanson DM, Skoglund LA. Analgesic effect of oral ibuprofen 400, 600, and 800 mg; paracetamol 500 and 1000 mg; and paracetamol 1000 mg plus 60 mg codeine in acute postoperative pain: a single-dose, randomized, placebo-controlled, and double-blind study. Eur J Clin Pharmacol. 2021 Dec;77(12):1843-1852. doi: 10.1007/s00228-021-03231-9. Epub 2021 Oct 16.
PMID: 34655316DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 12, 2008
First Posted
June 17, 2008
Study Start
June 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 6, 2011
Record last verified: 2009-02