NCT03874936|CompletedPhase 2/3DMC
The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.
PAODEX
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
90
1 country
1
Study Start
November 12, 2020
Actual (reported)Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 6, 2019
Actual (reported)March 14, 2019
Actual (reported)November 12, 2020
Actual (reported)December 31, 2022
Actual (reported)December 31, 2023
Actual (reported)Cumulated postoperative morphine consumption in milligrams after 48 hours.
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg.
0-48 hours postoperatively
Postoperative pain intensity after 48 hours.
24, 48 hours postoperatively
Cumulated postoperative morphine consumption from 48 hours until day 14 post operation
48 hours - day 14 postoperatively
24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours.
24mg intravenous Dexamethasone just before the operation and placebo which is 6ml of isotonic sodium chloride (9mg/ml, 'normal' saline) after 24 hours
Administrated i.v.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Dexamethasone 24mg Solution for Injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Dexamethasone 24mg Solution for Injection
Named ingredient: Dexamethasone
View registry recordOdense University Hospital
Odense, 5000, Denmark
Lindberg-Larsen V, Lindberg-Larsen M, Ovesen O, Zwisler ST, Lindholm P, Hebsgaard S, Christensen R, Overgaard S. Effect of high-dose dexamethasone on morphine use after periacetabular osteotomy for hip dysplasia: a randomized double-blind placebo-controlled single center trial. Acta Orthop. 2025 Jun 1;96:413-420. doi: 10.2340/17453674.2025.43903.
Viktoria Lindberg-Larsen, MD, PhD
Dept. of Anesthesiology and Intensive Care Medicine, Odense University Hospital
90 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2019
First Posted
March 14, 2019
Study Start
November 12, 2020
Actual (reported)Postoperative nausea and vomiting
24 and 48 hours postoperatively
Antiemetic consumption
0-48 hours postoperatively
Sleep
0-7 days postoperatively
Cumulated postoperative morphine consumption in milligrams after 24hours.
0-24 hours postoperatively
Cumulated antiemetic consumption
0-24 hours postoperatively
Fasting blood glucose
0 hours, 6 hours, 24 hours, 48 hours (72 hours)
placebo intravenous just before the operation and repeated after 24 hours
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 31, 2023
Actual (reported)Last Updated
April 2, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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