drugset / Trial / NCT03454217

Impact of Tramadol and Oxycodone on Sleep Apnea

NCT03454217

Phase 4 Completed 60 enrolled Centre Hospitalier Universitaire Vaudois
RandomizedParallel-groupTriple-blindTreatment

Summary

Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.

Timeline

Start
2018-03-01
Primary completion
2020-09-30
Completion
2020-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxycodone Other / unclassified 5 mg
Comparator Oxycodone Other / unclassified 10 mg
Comparator Tramadol Other / unclassified 50 mg
Comparator Tramadol Other / unclassified 100 mg

Indications