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

Completed · Not applicable

Conditions studied: Pregnancy, Unplanned

In brief

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.

Key facts

Study ID

NCT01994317

Run by

Planned Parenthood League of Massachusetts

People needed

196

Starts

2013-11-01

Expected to finish

2015-07-01

Last updated by the study team

2015-08-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Planned Parenthood — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.