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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy, Unplanned

Intervention / Treatment
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* Other: Algorithm
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard sedation dose<br>IV sedation dose calculated using current standard of care | Other: Standard care<br>* IV sedation dosing calculated by standard care.<br>|
| Experimental: Algorithm<br>IV sedation dose calculated by study algorithm | Other: Algorithm<br>* IV sedation dosing calculated by algorithm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |