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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard sedation dose | Active Comparator | IV sedation dose calculated using current standard of care |
|
| Algorithm | Experimental | IV sedation dose calculated by study algorithm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algorithm | Other | IV sedation dosing calculated by algorithm |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Doses given over the duration of the study | 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. | Measured on Day 1 (day of enrollment), intraoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD, MPH | PPLM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D000465 | Algorithms |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D055641 | Mathematical Concepts |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Standard care |
| Other |
IV sedation dosing calculated by standard care. |
|
| 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 |
| Physician assessment of pain control | 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. | Measured on Day 1 (day of enrollment), post-operatively |
| D017530 | Health Care Quality, Access, and Evaluation |