Pregnancy, Unplanned
Conditions
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.
Interventions
OTHERAlgorithm
IV sedation dosing calculated by algorithm
OTHERStandard care
IV sedation dosing calculated by standard care.
Sponsors
Society of Family Planning
Planned Parenthood League of Massachusetts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain with suction curettage | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain with paracervical block | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Doses given over the duration of the study | 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 | 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. |
Countries
United States
Outcome results
None listed