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

Pregnancy, Unplanned Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994317
• Other study ID #: SFPRF7-6
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: August 14, 2015
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Planned Parenthood League of Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy, Unplanned

Intervention

Other:
• Algorithm
IV sedation dosing calculated by algorithm
• Standard care
IV sedation dosing calculated by standard care.

Locations

Country	Name	City	State
United States	Planned Parenthood	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No