NCT01994317

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Planned Parenthood League of Massachusetts · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pregnancy, Unplanned

Interventions

Type	Name	Description
OTHER	Algorithm	IV sedation dosing calculated by algorithm
OTHER	Standard care	IV sedation dosing calculated by standard care.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-11-25
• Last updated: 2015-08-17

Locations

1 site across 1 country: United States