Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)

March 16, 2016 updated by: Planned Parenthood League of Massachusetts

A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion

The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Planned Parenthood League of Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 or older.
  • Undesired pregnancy between 6 0/7-12 6/7 weeks gestation.
  • Has already signed consent for pregnancy termination.
  • Eligible for IV sedation per clinic protocol.

Exclusion Criteria:

  • Under 120 lbs.
  • Allergies to any of the drugs being studied.
  • Chronic narcotics, barbiturates or benzodiazepine use within the past year.
  • History of IV drug use within the last year.
  • Inability to give informed consent.
  • Does not speak English or Spanish and does not have translator for all study procedures
  • Previously participated in study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain scale

Secondary Outcome Measures

Outcome Measure
Measures of satisfaction, side effects, recovery time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Planned Parenthood League of Massachusetts

Investigators

  • Principal Investigator: Jane Doe, Planned Parenthood League of Massachusetts

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

June 15, 2006

First Submitted That Met QC Criteria

June 15, 2006

First Posted (ESTIMATE)

June 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-P-002284/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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