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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
196
IV sedation dosing calculated by algorithm
IV sedation dosing calculated by standard care.
Planned Parenthood
Boston, Massachusetts, United States
Pain with suction curettage
Subjects' pain score with suction curettage on a 0-100 21-point scale
Time frame: Measured on Day 1 (day of enrollment), immediately (within one minute) after completion of suction curettage and speculum removal
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured on Day 1 (day of enrollment), 15 minutes post-operatively
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