CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 118 enrolled
Drug / intervention
ketorolac +2 moredrug
Likely dose
Not stated in 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/NCT02956616
NCT02956616Phase 2Completed

Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay

Montefiore Medical Center·interventional·Posted Nov 7, 2016·Updated Apr 25, 2019

In Brief

A Phase 2 clinical trial evaluating ketorolac, Chewing Gum, and 1 other intervention for Cesarean Section. Completed, enrolled 118 participants across 1 site.

Detailed Summary

To determine whether women randomized to an enhanced recovery program will have improved postoperative outcomes including improved breastfeeding initiation and continuation, reduction in hospital length of stay without compromising patient satisfaction in comparison to standard postoperative recovery interventions.

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 7, 2016
Enrollment StartSep 1, 2017
Primary CompletionJun 15, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.7 years ago

Interventions

ketorolacdrug

Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.

Chewing Gumother

Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for a duration of 30 minutes at each time, based on a metanalysis and systematic review. Patient's will be encouraged on its use for return of bowel function.

Enhanced Recovery Protocolprocedure

enhanced recovery protocol (detailed previously) will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing and standing ketorolac for 24 hours postoperatively.