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

This study has been terminated.

(7% enrollment. Study terminated after a small number of recruited patients)

Sponsor:

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01011634

First received: November 9, 2009

Last updated: May 14, 2013

Last verified: May 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Undesired Intrauterine Pregnancy First Trimester Pregnancy	Drug: Intravenous moderate sedation versus oral medication	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Double Blinded, Placebo-controlled Randomized Control Trial Comparing Intravenous Moderate Sedation and Oral/Sublingual Analgesia/Anxiolysis for First Trimester Surgical Abortions

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Pain Score Within 5 Mins After Procedure [ Time Frame: within 5 mins after procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acceptability of Pain, Would They Choose the Same Regimen Again for Another Uterine Aspiration [ Time Frame: 30 min after procedure ] [ Designated as safety issue: No ]

Enrollment:	18
Study Start Date:	May 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Moderate sedation	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)
Active Comparator: Oral medication	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)

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Eligibility

Ages Eligible for Study:	16 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Intrauterine pregnancy <12 weeks gestation (as confirmed by ultrasound)
Ability to undergo outpatient abortion without an anesthesiologist
Age ≥ 16 years old
Informed consent prior to participation in study
English or Spanish language capacity (or staff or professional translator available for all study procedures)

Exclusion Criteria:

Possible ectopic pregnancy
Known allergy to study medications or misoprostol
Current unstable psychiatric disorder
Current alcohol/drug/narcotic/benzodiazepine/barbituate dependence within the previous 2 months
Weight < 50 kg

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011634

Locations

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:	Pratima Gupta, MD	University of California, San Francisco
Principal Investigator:	Karen Meckstroth, MD, MD	University of California, San Francisco

More Information

No publications provided

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01011634 History of Changes
Other Study ID Numbers:	H10873-28990-01
Study First Received:	November 9, 2009
Results First Received:	February 24, 2013
Last Updated:	May 14, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

abortion
uterine aspiration
pain control

ClinicalTrials.gov processed this record on June 18, 2013

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