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Inability to recruit more participants.
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Pain has been recognized to be the most common and predictable side effect of medication abortion, causing significant distress associated with the process. Yet there is little known about the appropriate management of pain during this process, with no current evidence based recommendations for optimal analgesic regimens during the first trimester.
The goal of this study is to evaluate the efficacy of oral methadone for pain control during medication abortion. The current medication regimen used to perform medication abortion is a dose of mifepristone (antiprogesterone) orally, followed by a dose of misoprostol (prostaglandin analogue) 24 to 72 hours later. Patients are prescribed a standard dose of ibuprofen 600-800mg tabs for pain control during the process. The investigators will conduct a non-randomized, pilot study with 25 patients evaluated at the Boston Medical Center family planning clinic at 10 weeks of gestation or less for medication abortion.
The primary objective of this research study is to determine the feasibility of enrolling patients in a study that requires the consumption of methadone for acute pain management for medication abortion. Secondary objectives include the assessment of pain using: pain scores at 0, 4, 8, and 24 hours following misoprostol, use of supplementary analgesia, reported side effects, and patient satisfaction
All participants will be instructed to take methadone 5 mg orally (1 tablet) simultaneously with the consumption of misoprostol. The participants will be evaluated using an 11 point numeric rating pain scale with 0 (no pain) and 10 (most severe pain). Patients will be given a telephone number to which they will be asked to text study staff indicating that misoprostol and methadone have been consumed. Study staff will phone the participants at 0, 4, 8 and 24 hours post misoprostol consumption to conduct a survey posing questions about maximum pain scores, compliance with study medication and any adverse effects experienced. Participants will also be contacted at 48 hours for further evaluation of any reported adverse events and 1 week post misoprostol to assess ease of study design and instructions, pain experience, perisomal view on consumption of methadone and patient satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral methadone | Experimental | Participants will be given a preemptive analgesic in addition to a standard dose of ibuprofen while undergoing early medication abortion with mifepristone and misoprostol (not provided as part of the study). All participants will also be provided with supplementary non- opioid analgesics to be used at their own discretion during the process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone Pill | Drug | All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at 24 Hours Post Medication Abortion | Pain will be assessed using measured by an 11-point numeric visual analogue (VAS); (0-10) where 0 is equivalent to no pain and 10 is the worst pain. Higher scores are associated with more pain. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at 8 Hours Post Medication Abortion | Pain will be assessed using measured by an 11-point numeric visual analogue (VAS); (0-10) where 0 is equivalent to no pain and 10 is the worst pain. Higher scores are associated with more pain. | 8 hours |
| Participant Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel A Achu, MD | Boston Medical Center, Anesthesiology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Methadone | Participants will be given a preemptive analgesic in addition to a standard dose of ibuprofen while undergoing early medication abortion with mifepristone and misoprostol (not provided as part of the study). All participants will also be provided with supplementary non- opioid analgesics to be used at their own discretion during the process. Methadone Pill: All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose. Ibuprofen: All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Methadone | Participants will be given a preemptive analgesic in addition to a standard dose of ibuprofen while undergoing early medication abortion with mifepristone and misoprostol (not provided as part of the study). All participants will also be provided with supplementary non- opioid analgesics to be used at their own discretion during the process. Methadone Pill: All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose. Ibuprofen: All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score at 24 Hours Post Medication Abortion | Pain will be assessed using measured by an 11-point numeric visual analogue (VAS); (0-10) where 0 is equivalent to no pain and 10 is the worst pain. Higher scores are associated with more pain. | Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available. | Posted | 24 hours |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Methadone | Participants will be given a preemptive analgesic in addition to a standard dose of ibuprofen while undergoing early medication abortion with mifepristone and misoprostol (not provided as part of the study). All participants will also be provided with supplementary non- opioid analgesics to be used at their own discretion during the process. Methadone Pill: All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose. Ibuprofen: All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours. |
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The study was halted prematurely as it was very difficult to recruit participants. Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Achu, MD | Boston Medical Center, Department of Anesthesiology | (617) 414-2000 | rachel.achu@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2021 | Dec 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
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| Ibuprofen | Drug | All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours. |
|
|
An investigator developed survey will be administered over the phone by study staff to assess participant satisfaction. Participants will be asked how satisfied they were with their pain management and a Likert scale will be used to collect responses. The response choices range from 0= very dissatisfied to 4= very satisfied. |
| 24 hours, 1 week |
| Adverse Events | An investigator developed survey will be administered over the phone by study staff to assess adverse events including dizziness, difficulty breathing, nausea or vomiting. | 24 hours, 48 hours, 1 week |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Pain Score at 8 Hours Post Medication Abortion | Pain will be assessed using measured by an 11-point numeric visual analogue (VAS); (0-10) where 0 is equivalent to no pain and 10 is the worst pain. Higher scores are associated with more pain. | Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available. | Posted | 8 hours |
|
|
| Secondary | Participant Satisfaction | An investigator developed survey will be administered over the phone by study staff to assess participant satisfaction. Participants will be asked how satisfied they were with their pain management and a Likert scale will be used to collect responses. The response choices range from 0= very dissatisfied to 4= very satisfied. | Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available. | Posted | 24 hours, 1 week |
|
|
| Secondary | Adverse Events | An investigator developed survey will be administered over the phone by study staff to assess adverse events including dizziness, difficulty breathing, nausea or vomiting. | Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available. | Posted | 24 hours, 48 hours, 1 week |
|
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D002264 |
| Carboxylic Acids |