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

Not Applicable

Completed

• Conditions: Pregnancy, Unplanned

• Registration Number: NCT01994317
• Lead Sponsor: Planned Parenthood League of Massachusetts

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain with suction curettage	Measured on Day 1 (day of enrollment), immediately (within one minute) after completion of suction curettage and speculum removal	Subjects' pain score with suction curettage on a 0-100 21-point scale

Secondary Outcome Measures

Name	Time	Method
Pain with paracervical block	Measured on Day 1 (day of enrollment), immediately after paracervical block	Pain with paracervical block will be measured (a) on a 21-point 0 to 100 scale (in increments of five), and (b) on a subjective scale of "no pain, mild pain, moderate pain or severe pain." Pain will be measured immediately after paracervical block.
Pain with cervical dilation	Measured on Day 1 (day of enrollment), immediately after cervical dilation	Pain with cervical dilation will be measured (a) on a 21-point 0 to 100 scale (in increments of five), and (b) on a subjective scale of "no pain, mild pain, moderate pain or severe pain." Pain with cervical dilation will be measured immediately after cervical dilation.
Post-operative pain	Measured on Day 1 (day of enrollment), 15 minutes post-operatively	Post-operative pain will be measured (a) on a 21-point 0 to 100 scale (in increments of five), and (b) on a subjective scale of "no pain, mild pain, moderate pain or severe pain." Pain will be measured 15 minutes post-operatively when the patient is in the recovery room.
Patient satisfaction with pain control	Measured on Day 1 (day of enrollment), 15 minutes post-operatively	Patients will be asked about their general satisfaction with pain control, what their pain was compared to what they expected, whether they would chose the same pain management strategy again, and whether they would recommend their strategy of pain management to a friend.
Side effects	Measured on Day 1 (day of enrollment), 15 minutes post-operatively	Investigators will assess side effects for all patients, including nausea, vomiting, dizziness, and drowsiness.

Trial Locations

Locations (1)

Planned Parenthood; 🇺🇸 Boston, Massachusetts, United States