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Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions

NCT01011634 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-05-16

Study results available
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Summary

In the United States, the majority of first-trimester surgical abortions are performed in outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain control. The specific aim of this study is to evaluate the equivalency of intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg) for first-trimester surgical abortions. The investigators hypothesize that oral moderate sedation and intravenous moderate sedation will be equivalent in controlling pain as measured by a difference of +/- 10 on a 100-point (range 0-100) visual analog pain scale.

Conditions

  • Undesired Intrauterine Pregnancy
  • First Trimester Pregnancy

Interventions

DRUG

Intravenous moderate sedation versus oral medication

Intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg)

Sponsors & Collaborators

Principal Investigators

  • Pratima Gupta, MD · University of California, San Francisco

  • Karen Meckstroth, MD, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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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 NCT01011634 on ClinicalTrials.gov