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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy, Unplanned
• Intervention / Treatment: Other: Standard care; Other: Algorithm

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Planned Parenthood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard sedation dose; IV sedation dose calculated using current standard of care	Other: Standard care; IV sedation dosing calculated by standard care.
Experimental: Algorithm; IV sedation dose calculated by study algorithm	Other: Algorithm; IV sedation dosing calculated by algorithm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain with 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.	Measured on Day 1 (day of enrollment), immediately after paracervical block
Pain with 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.	Measured on Day 1 (day of enrollment), immediately after cervical dilation
Post-operative pain	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.	Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Patient satisfaction with pain control	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.	Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Side effects	Investigators will assess side effects for all patients, including nausea, vomiting, dizziness, and drowsiness.	Measured on Day 1 (day of enrollment), 15 minutes post-operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Doses given over the duration of the study	To assess whether use of the algorithm changes physician's behavior in the standard care arm, investigators will also examine doses given over the duration of the study, to see if a "learning curve" develops among the physicians based on their experience with the algorithm.	Measured on Day 1 (day of enrollment), intraoperatively
Physician assessment of pain control	Investigators will also have the physician assess patients' pain control, whether they felt the dose was appropriate and how easy or difficult it was to determine the patients' doses of pain medication.	Measured on Day 1 (day of enrollment), post-operatively

Collaborators and Investigators

• Sponsor: Planned Parenthood League of Massachusetts
• Collaborators: Society of Family Planning

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: SFPRF7-6