Maxi-Analgesic Study

Phase 3

Completed

• Conditions: Post-operative Analgesia; Surgery - Pain management

• Registration Number: ACTRN12606000291583
• Lead Sponsor: AFT Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Undergoing oral surgery (including extraction of at least one lower 8th molar tooth under local or general anaesthetic).

Exclusion Criteria

Consent:• Patient declinedStudy contra-indications:• Too young (< 16 years)• Other Non-steroidal anti-inflammatory drug (NSAID) (other than aspirin = 150mg mg/day) or opioid within 24 hours prior to operation• Treatment within 12 hours with other paracetamol or paracetamol containing medicines (e.g. cold treatments) • Pregnant or possibly pregnant• Breastfeeding• Neurological disorder relating to pain perception• History of drug addiction• Currently on another experimental agent• Weight < 50kg• Belief by the clinician that participation in the study may compromise the patient NSAID and/or paracetamol contra-indications:• Hypersensitive to aspirin or other NSAID• Hypersensitive to paracetamol• Severe known haemopoetic, renal* or hepatic disease• GI ulcer, severe asthma, allergy etc• Currently on ACE inhibitor, warfarin, steroid (other than dexamethasone intra-operatively)**, cyclosporin, tacrolimus, methotrexate• Severe local infection. Immunosuppressed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified