Maxi-Analgesic Study

Maxi-Analgesic Study. A prospective, parallel group, double-blind comparison of the analgesic effect of a combination of paracetamol and ibuprofen, paracetamol alone or ibuprofen alone in patients with post-operative pain.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000291583

Acronym

Nil

Enrollment

120

Registered

2006-07-10

Start date

2005-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Measurement of relative differences in post-operative analgesia with 3 different treatments assessed by measurement of reduction in visual analogue scales AUC measurements. Investigators and patients are blinded until after the study is completed, the study database loaded and verified.

Interventions

Post-operative analgesia with Oral Maxigesic (paracetamol 1g + Ibuprofen 300mg) four times a day for 48 hours post-operatively

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

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.

Outcome results