Clinical trial NCT01994317: Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion
Official title: Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, Unplanned
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2013-11-25
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain with suction curettage
timeFrame: Measured on Day 1 (day of enrollment), immediately (within one minute) after completion of suction curettage and speculum removal
Secondary outcomes:
measure: Pain with paracervical block
timeFrame: Measured on Day 1 (day of enrollment), immediately after paracervical block
measure: Pain with cervical dilation
timeFrame: Measured on Day 1 (day of enrollment), immediately after cervical dilation
measure: Post-operative pain
timeFrame: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
measure: Patient satisfaction with pain control
timeFrame: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
measure: Side effects
timeFrame: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
Other outcomes:
measure: Doses given over the duration of the study
timeFrame: Measured on Day 1 (day of enrollment), intraoperatively
measure: Physician assessment of pain control
timeFrame: Measured on Day 1 (day of enrollment), post-operatively
Locations:
city: Boston
country: United States
facility: Planned Parenthood
state: Massachusetts
Study officials:
affiliation: PPLM
name: Principal Investigator, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: