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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014