drugset / Trial / NCT02238340

Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery

NCT02238340

Phase 4 Completed 40 enrolled Hospital Central Dr. Luis Ortega
RandomizedParallel-groupTriple-blindTreatment

Summary

Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the patient, including significant cardiovascular and respiratory complications. Apart from the human suffering that is undeniable pain. Schemes oral analgesia with opioids for the treatment of DAPO, have shown to be as or more effective than intravenous or epidural regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20) undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at rest and effort, requirement for rescue intravenous morphine and incidence of side effects to the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and patient satisfaction.

Timeline

Start
2012-03
Primary completion
2012-08
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxycodone Other / unclassified 10 mg Oral
Subject Oxycodone Other / unclassified 20 mg Oral
Background Dexamethasone Small molecule
Background Ketoprofen Small molecule
Background Morphine Other / unclassified Intravenous
Background dipirone Unknown

Indications

No indication recorded.