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
  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)

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Possible ectopic pregnancy
  2. Known allergy to study medications or misoprostol
  3. Current unstable psychiatric disorder
  4. Current alcohol/drug/narcotic/benzodiazepine/barbituate dependence within the previous 2 months
  5. 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 April 22, 2014