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

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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

Tracking Information
First Submitted Date  ICMJE November 1, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date August 17, 2015
Study Start Date  ICMJE November 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 19, 2013)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion
Official Title  ICMJE Use of an Algorithm to Determine IV Sedation Dosing During First-trimester Surgical Abortion
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pregnancy, Unplanned
Intervention  ICMJE
  • Other: Algorithm
    IV sedation dosing calculated by algorithm
  • Other: Standard care
    IV sedation dosing calculated by standard care.
Study Arms  ICMJE
  • Active Comparator: Standard sedation dose
    IV sedation dose calculated using current standard of care
    Intervention: Other: Standard care
  • Experimental: Algorithm
    IV sedation dose calculated by study algorithm
    Intervention: Other: Algorithm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2015)
196
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
166
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994317
Other Study ID Numbers  ICMJE SFPRF7-6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Planned Parenthood League of Massachusetts
Study Sponsor  ICMJE Planned Parenthood League of Massachusetts
Collaborators  ICMJE Society of Family Planning
Investigators  ICMJE
Principal Investigator: Principal Investigator, MD, MPH PPLM
PRS Account Planned Parenthood League of Massachusetts
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP