Analgesic Effect of Paracetamol, Paracetamol + Codeine, Ibuprofen and Their Combination
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine whether the combination of paracetamol (acetaminophen) and other NSAIDs with or without weak opioids can give synergistic analgesic effect.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain, Postoperative |
Drug: Ibuprofen + Paracetamol Drug: Ibuprofen + Paracetamol + Codeine Drug: Paracetamol + Codeine Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Analgesic Effect of Ibuprofen 400 mg/Paracetamol 1000 mg, Ibuprofen 400 mg/ Paracetamol 1000 mg/60 mg Codeine, and Paracetamol 1000 mg/Codeine 60 mg: A Single-dose, Randomized, Placebo-controlled and Double-blind Study |
- Sum pain intensity SPI (0-10 Numerical Rating Scale) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Sum pain intensity difference score (PID) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Overall assessment of efficacy (4-point Verbal Rating Scale) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Adverse effects AE (Specific reporting of AE - type, duration and severity) [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ibuprofen + Paracetamol
Single oral dose of ibuprofen 400 mg + paracetamol (acetaminophen) 1000 mg
|
Drug: Ibuprofen + Paracetamol
Single oral dose of ibuprofen 400 mg combined with paracetamol (acetaminophen) 1000 mg in gelatine capsules
Other Names:
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Experimental: Ibuprofen + Paracetamol + Codeine
Single oral dose of ibuprofen 400 mg + paracetamol (acetaminophen) 1000 mg + codeine 60 mg
|
Drug: Ibuprofen + Paracetamol + Codeine
Single oral dose of ibuprofen 400 mg combined with paracetamol (acetaminophen) 1000 mg and codeine 60 mg in gelatine capsules
Other Names:
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Active Comparator: Paracetamol + Codeine
Single oral dose of paracetamol (acetaminophen) 1000 mg + codeine 60 mg
|
Drug: Paracetamol + Codeine
Single oral dose of paracetamol (acetaminophen) 1000 mg combined with codeine 60 mg in gelatine capsules
Other Names:
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Placebo Comparator: Placebo
Single oral dose of lactose as placebo
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Drug: Placebo
Single oral dose of lactose as placebo in gelatine capsules
Other Names:
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Detailed Description:
Combining paracetamol and other NSAIDs could give a theoretical synergistic analgesic effect according to already known or assumed mechanisms of action. Synergism is defined as an additive or supra-additive effect not achieved by one of the drugs alone. Such synergism is shown in clinical studies between acetaminophen and naproxen in coxarthrosis and rheumatoid arthritis. Later, a significant additive effect of 100 mg diclofenac with 1 g acetaminophen was demonstrated in a dental pain model.
One review article conclude that acetaminophen and NSAIDs may be appropriate to combine, and the combination is superior to acetaminophen, but not to NSAIDs alone. This view is contested by another review article which concludes that paracetamol may enhance the analgesic effect when added to an NSAID. In both reviews the authors also state that the clinical trials are too few, with different drug formulations, and different pain models not allowing definite conclusions.
There seems to be a need for studies investigating the potential synergistic effects of paracetamol combined with another NSAID displaying similar pharmacokinetic characteristics. To the best of our knowledge no published study has investigated the analgesic effect of the combination of ibuprofen and paracetamol, ibuprofen and paracetamol + codeine versus placebo (i.e. negative control to adjust for possible analgesic placebo effects) and the best standard analgesic treatment (i.e. paracetamol + codeine) as a positive control group.
Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients of ASA class I in need of surgical removal of impacted third molars and with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars.
Exclusion Criteria:
- Females stating not suspected or not verified pregnancy after being questioned by investigator.
- Patients who have used analgesics for 3 days prior to the day of surgery.
- Patients with known active gastrointestinal bleeding or ulcer.
- Patients with any known hypersensitivity to NSAIDs.
- Patients with other drug treatment than contraceptives.
- Patients smoking before taking the test-drug or during the observation period.
- Drug addicts or rehabilitated drug addicts.
- 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.
Contacts and Locations| Contact: Lasse A Skoglund, DDS, DSci | 004722844672 | lasses@odont.uio.no |
| Contact: Per Skjelbred, DDS, MD, PhD | 004722118484 | p.skjelbred@ulleval.no |
| Norway | |
| Ullevaal University Hospital | Recruiting |
| Oslo, Norway, NO-0407 | |
| Contact: Lasse A Skoglund, DDS, DSci 004722844672 lasses@odont.uio.no | |
| Contact: Gaute Lyngstad, DDS 004722844673 gautelyn@odont.uio.no | |
| Principal Investigator: Gaute Lyngstad, DDS | |
| Sub-Investigator: Lasse A Skoglund, DDS, DSci | |
| Study Director: | Lasse A Skoglund, DDS, DSci | University of Oslo |
| Principal Investigator: | Gaute Lyngstad, DDS | University of Oslo |
More Information
Publications:
| Responsible Party: | Professor Lasse A. Skoglund, DDS, DSci, University of Oslo |
| ClinicalTrials.gov Identifier: | NCT00921700 History of Changes |
| Other Study ID Numbers: | PARIBU-022, EUDRACT No. 2007-001778-10 |
| Study First Received: | June 15, 2009 |
| Last Updated: | March 2, 2010 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Medicines Agency Norway: Norwegian Social Science Data Services |
Keywords provided by Ullevaal University Hospital:
|
Paracetamol Acetaminophen Ibuprofen |
Pain Postoperative pain third molar |
Additional relevant MeSH terms:
|
Analgesics Analgesics, Non-Narcotic Analgesics, Opioid Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Acetaminophen Ibuprofen Codeine Antipyretics Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013