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Evaluation of Oral Midazolam in First-trimester Surgical Abortions

NCT01830881 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-06-25

Study results available
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Summary

The purpose of this study is to determine the level of pain, anxiety and side effects that women experience with a surgical abortion and the effect that the anti-anxiety medication, midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead of the standard pain treatment of only ibuprofen and a PCB.

Conditions

Interventions

DRUG

Midazolam

5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure

DRUG

Ibuprofen

800 mg oral ibuprofen 30-60 minutes prior to procedure

OTHER

Placebo-Cherry syrup

5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure

DRUG

Lidocaine

injection of 20 mL 1% lidocaine without epinephrine

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Lisa Bayer, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01830881 on ClinicalTrials.gov