CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Ketorolac +1 moredrug
Likely dose
Ketorolac 30 mgfrom 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/NCT02509312
NCT02509312Phase 4Completed

A Prospective, Randomized, Control Trial of Ketorolac Versus Placebo on Opioid Analgesic Use, Estimated Blood Loss and Complications Following Cesarean Delivery With Epidural Morphine

University Hospitals Cleveland Medical Center·interventional·Posted Jul 28, 2015·Updated Jun 7, 2022

In Brief

A Phase 4 clinical trial evaluating Ketorolac and Placebo for Analgesia, Obstetrical and 7 related conditions. Completed, enrolled 70 participants across 1 site.

Detailed Summary

In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control. Patients will be randomized to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive ketorolac at cord clamp and three additional doses every 6 hours (total 4 doses/24 hours). Those in the placebo group will receive normal saline during those time periods. Our primary outcome is to assess whether intra-operative ketorolac increases the estimated blood loss during Cesarean delivery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 28, 2015
Enrollment StartMay 1, 2016
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.9 years ago

Interventions

Ketorolacdrug

Patients in the experimental arm will receive ketorolac 30 mg in 1 ml at the time of cord clamp and then for 3 more doses every 6 hours.

Placebodrug

Patients in the control arm will receive normal saline 1 ml at the time of cord clamp and then for 3 more doses every 6 hours.