Medical Abortion, Pain
Conditions
Keywords
Oral methadone, Pain control
Brief summary
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.
Detailed description
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.
Interventions
DRUGMethadone Pill
All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose.
DRUGIbuprofen
All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours.
Sponsors
Boston Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women requesting medication abortion up to 10 weeks gestation * Fluent English speaking * Able and willing to receive and send text messages and receive phone calls * Opioid naive * Healthy patients with no significant comorbidities
Exclusion criteria
* Any history of drug or alcohol use, opioid use in last 30 days, chronic use of pain medications, or use of benzodiazepines. * Any chronic disease including renal, liver, respiratory or cardiac disease * Any known allergies to mifepristone, misoprostol, nonsteroidal anti-inflammatory drugs (such as ibuprofen) and methadone. * Known history of QT prolongation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 24 Hours Post Medication Abortion | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 8 Hours Post Medication Abortion | 8 hours | 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. |
| Participant Satisfaction | 24 hours, 1 week | 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. |
| Adverse Events | 24 hours, 48 hours, 1 week | An investigator developed survey will be administered over the phone by study staff to assess adverse events including dizziness, difficulty breathing, nausea or vomiting. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Oral Methadone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: 24 hours
Population: Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.
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.
Time frame: 24 hours, 48 hours, 1 week
Population: Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.
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.
Time frame: 8 hours
Population: Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.
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.
Time frame: 24 hours, 1 week
Population: Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.