drugset / Trial / NCT01586143

Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain

NCT01586143 ↗

Phase 3 Completed 43 enrolled University Hospital, Clermont-Ferrand
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.

Timeline

Start
2012-05
Primary completion
2013-05
Completion
2013-05

Outcome

Met primary endpoint

paper The difference of pain intensity between groups was 0.30 with 2-sided IC90% = [-0.38 - 0.98], not including the non-inferiority margin ( ∆ = 1). PMID 26000668 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 125 mg Other
Subject Acetaminophen Small molecule 1 g Other

Indications

No indication recorded.