Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994317
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : August 17, 2015
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pregnancy, Unplanned Other: Algorithm Other: Standard care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion
Study Start Date : November 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994317


Locations
Layout table for location information
United States, Massachusetts
Planned Parenthood
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Society of Family Planning
Investigators
Layout table for investigator information
Principal Investigator: Principal Investigator, MD, MPH PPLM
Layout table for additonal information
Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT01994317    
Other Study ID Numbers: SFPRF7-6
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015