drugset / Trial / NCT03049878

Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery

NCT03049878

Phase 4 Completed 32 enrolled University of Roma La Sapienza
RandomizedParallel-groupTriple-blindTreatment

Summary

Objectives: The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar. Materials and Methods: The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets.

Timeline

Start
2013-02-21
Primary completion
2015-09-20
Completion
2016-09-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule Oral
Comparator Codeine Small molecule Oral

Indications

No indication recorded.