Skip to main content
OpenTrials
Completed

NCT Number: NCT01994317

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy, Unplanned

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Algorithm

Other

IV sedation dosing calculated by algorithm

Standard care

Other

IV sedation dosing calculated by standard care.

Primary outcomes

  1. Pain with suction curettage

    Time frame: 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 outcomes

  1. Pain with paracervical block

    Time frame: 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.

  2. Pain with cervical dilation

    Time frame: 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.

  3. Post-operative pain

    Time frame: 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.

  4. Patient satisfaction with pain control

    Time frame: 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.

  5. Side effects

    Time frame: 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.

Other outcomes

  1. Doses given over the duration of the study

    Time frame: Measured on Day 1 (day of enrollment), intraoperatively

    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.

  2. Physician assessment of pain control

    Time frame: Measured on Day 1 (day of enrollment), post-operatively

    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.

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Collaborators

  • Society of Family Planning

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.