drugset / Trial / NCT02711449

Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

NCT02711449 ↗

Phase 2 Completed 78 enrolled Jakob Kleif Zealand University Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To test whether 125 mg preoperative methylprednisolone intravenously can reduce postoperative pain after laparoscopy for suspected appendicitis and to test whether preoperative methylprednisolone can reduce postoperative fatigue, increase quality of sleep, reduce nausea or vomiting, reduce duration of convalescence and increase overall quality of recovery after laparoscopy for suspected appendicitis.

Timeline

Start
2016-04
Primary completion
2016-09
Completion
2016-09

Outcome

Missed primary endpoint

paper The estimated effect of 125 mg of methylprednisolone on pain at rest during the first 3 days after surgery was a nonsignificant increase of 0.2 (95% confidence interval, -0.5 to 0.9; P = .571). PMID 29200067 ↗

paper A 125-mg dose of methylprednisolone given intravenously 30 minutes before laparoscopic surgery for appendicitis seemed no better than placebo at providing a clinical meaningful reduction in postoperative pain at rest. PMID 29200067 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 125 mg Intravenous

Indications