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

NCT01011634 | Terminated Phase 4 Results DMC

• 1 other identifier: H10873-28990-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

abortion; uterine aspiration; pain control

Outcome Measures

Primary Outcomes (1)

• Pain Score Within 5 Mins After Procedure

  within 5 mins after procedure

Secondary Outcomes (1)

• Acceptability of Pain, Would They Choose the Same Regimen Again for Another Uterine Aspiration

  30 min after procedure

Study Arms (2)

Moderate sedation

ACTIVE COMPARATOR

Drug: Intravenous moderate sedation versus oral medication

Oral medication

ACTIVE COMPARATOR

Drug: Intravenous moderate sedation versus oral medication

Interventions

Intravenous moderate sedation versus oral medication DRUG

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)

Moderate sedation; Oral medication

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Karen Meckstroth, MD
• Organization: UCSF

meckstrothk@obgyn.ucsf.edu

415 206-8713

Study Officials

• Pratima Gupta, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Karen Meckstroth, MD, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: May 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 16, 2013
• Results First Posted: May 16, 2013

Record last verified: 2013-05

Locations

US (1)