Last reviewed · How we verify

NCT03874936: PAODEX

The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.

Completed Phase 2, PHASE3 Last updated 2 April 2024
What this trial tests

Phase 2, PHASE3 trial testing Dexamethasone 24mg Solution for Injection in Dexamethasone in 90 participants. Completed in 31 December 2023.

Timeline
12 November 2020
Primary endpoint
31 December 2022
31 December 2023

Quick facts

Lead sponsorOdense University Hospital
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment90
Start date12 November 2020
Primary completion31 December 2022
Estimated completion31 December 2023
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Odense University Hospital

Who can join

18 and older, any sex, with Dexamethasone or Hip Dysplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an investigator-initiated, Danish mono-center, randomized, placebo-controlled, parallel group, double-blind, superiority trial of dexamethasone on postoperative pain management on patients undergoing operation for hip dysplasia with the periacetabular osteotomy procedure (PAO). 90 adults undergoing PAO will be enrolled. The primary outcome is to compare the effect of dexamethasone relative to placebo on cumulated postoperative morphine consumption at 48 hours. Key secondary outcomes include comparing the effect of repeated doses of dexamethasone relative to a single dose on cumulated postoperative morphine consumption at 48 hours, and to determine if dexamethasone is superior to placebo for: Perception of pain intensity, prevalence and degree of postoperative nausea and vomiting, and patient-reported outcome measures.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.
    Weibel S, Rücker G, Eberhart LH, Pace NL, et al · · 2020 · cited 125× · PMID 33075160 · DOI 10.1002/14651858.cd012859.pub2
  2. Effect of high-dose dexamethasone on morphine use after periacetabular osteotomy for hip dysplasia: a randomized double-blind placebo-controlled single center trial.
    Lindberg-Larsen V, Lindberg-Larsen M, Ovesen O, Zwisler ST, et al · · 2025 · PMID 40460271 · DOI 10.2340/17453674.2025.43903

Verify or expand the search:

Other recruiting trials for Dexamethasone

Currently open trials in the same condition.

Other Odense University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03874936.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing