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

Planned Parenthood League of Massachusetts

Status

Completed

Conditions

Pregnancy, Unplanned

Treatments

Other: Algorithm

Other: Standard care

Study type

Interventional

Funder types

Other

Identifiers

NCT01994317

SFPRF7-6

Details and patient eligibility

About

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.

Enrollment

196 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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