CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 239 enrolled
Drug / intervention
Oral Oxycodon +1 moredrug
Likely dose
Oral Oxycodon 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01115101
NCT01115101Phase 4Completed
CompareCT.gov

A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide

Max Dieterich·interventional·Posted May 4, 2010·Updated Dec 12, 2016

In Brief

A Phase 4 clinical trial evaluating Oral Oxycodon and Piritramid for Pain. Completed, enrolled 239 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate adequate pain treatment for patients after cesarean. In this study oral opioids were compared to intravenous opioids as they are supposed to provide superior pain control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesGermany
CollaboratorsUniversity of Rostock

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2010
Enrollment StartJul 1, 2009
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.2 years ago

Interventions

Oral Oxycodondrug

Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.

Piritramiddrug

Patients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9% sodium chloride solution containing 60mg piritramide. Bolus injection of 0.5ml was administered by the patient herself if needed, with a lock out interval of 5 minutes Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. The PCA was discontinued after 24 hours or earlier if demanded.