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Oral Sedation During Cervical Dilator Placement

NCT03202550 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-03-30

Study results available
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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).

Conditions

  • Oral Sedation and Cervical Dilator Pain

Interventions

DRUG

Oxycodone and Lorazepam (Active Comparator)

Oxycodone and Lorazepam

DRUG

Placebo Comparator

Placebo oral pills

Sponsors & Collaborators

Principal Investigators

  • Carolyn Sufrin · Johns Hopkins University

  • Jessica K Lee, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2019-05-28
Completion
2019-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03202550 on ClinicalTrials.gov