Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-07-31

Brief Summary

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This study aims to compare an algorithm for IV sedation dosing to the current standard of care in patients undergoing first trimester surgical abortion. The primary outcome is subjects' pain score with suction curettage on a 0-100 21-point scale. Secondary outcomes include pain scores with cervical dilation and 15 minutes post-procedure, subjective pain ratings, incidents of side effects and adverse events, the frequency of additional doses of medication, recovery room time, and physician assessment of and satisfaction with pain control. Investigators hypothesize that this algorithm will result in improved pain control, decreased frequency of additional medication doses, improved patient and physician satisfaction, without differences in side effects, adverse events or recovery room time.

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Detailed Description

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Conditions

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Pregnancy, Unplanned

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard sedation dose

IV sedation dose calculated using current standard of care

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

IV sedation dosing calculated by standard care.

Algorithm

IV sedation dose calculated by study algorithm

Group Type EXPERIMENTAL

Algorithm

Intervention Type OTHER

IV sedation dosing calculated by algorithm

Interventions

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Algorithm

IV sedation dosing calculated by algorithm

Intervention Type OTHER

Standard care

IV sedation dosing calculated by standard care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women age 18 or older seeking surgical abortion at Planned Parenthood League of Massachusetts (PPLM)
* Gestational age less than or equal to 13+6, confirmed by ultrasound
* Eligible for surgical abortion according to PPLM protocols
* Eligible for IV sedation per PPLM protocol, and desiring IV sedation for pain management

Exclusion Criteria

* Choice of local anesthesia for pain control
* Hypersensitivity to midazolam or fentanyl
* Ineligible for IV sedation per PPLM protocol
* Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
* Unable or unwilling to complete required study procedures
* Previous participation in the study

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes