CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
Oxycodone and Lorazepam (Active Comparator) +1 moredrug
Likely dose
Oxycodone and Lorazepam (specific doses not stated)AI-extracted
Key inclusion· 4
  • ✓Women aged 18–50 years
  • ✓English speaking
  • ✓Intrauterine pregnancy (viable or non-viable) between 17w0d and 23w6d gestational age
  • ✓Has a support person present at time of procedure
Key exclusion· 3
  • ✕Non-English speaking
  • ✕Currently taking daily benzodiazepine or opiate
  • ✕Known allergy or contraindication to NSAIDs, opiates, or benzodiazepines

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

Search/NCT03202550
NCT03202550Phase 4Completed
CompareCT.gov

Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial

Johns Hopkins University·interventional·Posted Jun 28, 2017·Updated Mar 30, 2020

In Brief

A Phase 4 clinical trial evaluating Oxycodone and Lorazepam (Active Comparator) and Placebo Comparator for Oral Sedation and Cervical Dilator Pain. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on pain scores during cervical dilator placement prior to dilation and evacuation (D\&E).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Sedation and Cervical Dilator Pain
CountriesUnited States
CollaboratorsSociety of Family Planning

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 28, 2017
Enrollment StartJun 28, 2017
Primary CompletionMay 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.0 years ago

Interventions

Oxycodone and Lorazepam (Active Comparator)drug

Oxycodone and Lorazepam

Placebo Comparatordrug

Placebo oral pills