Acute Pain
Conditions
Brief summary
Medical abortion has been associated with significant pain. The objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. Investigators will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.
Interventions
DRUGPregabalin
Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
DRUGPlacebo
Matching placebo capsule with excipient to match Pregabalin
Sponsors
Society of Family Planning
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Requested and consented for pregnancy termination by medical abortion * Willing and able to complete multiple electronic surveys
Exclusion criteria
* Previous participation in this trial * Current use of pregabalin or gabapentin * Contraindication to medical abortion with mifepristone and misoprostol * Contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or pregabalin * Unable to understand and sign written informed consents in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Pain Score Over Study Period | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) | reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Ibuprofen 800mg Tablets Used | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) | summed number of tablets used by each participant over the 72 hour study period |
| Number of Oxycodone/Acetominophen Tablets (5/325mg) Used | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) | summed number of tablets used by each participant over the 72 hour study period |
| Number of Participants Ever Experiencing Different Symptoms During Abortion | Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours) | A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events. |
| Satisfaction With Analgesia | Asked at time point of 24 hours | 5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding) | 55 |
| Placebo Placebo: Matching placebo capsule with excipient to match Pregabalin | 52 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo | Pregabalin |
|---|---|---|---|
| Age, Continuous | 27.22 years STANDARD_DEVIATION 5.71 | 27.19 years STANDARD_DEVIATION 6.02 | 27.25 years STANDARD_DEVIATION 5.45 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 12 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 44 Participants | 21 Participants | 23 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 11 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Female | 107 Participants | 52 Participants | 55 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 52 |
| other Total, other adverse events | 0 / 55 | 0 / 52 |
| serious Total, serious adverse events | 0 / 55 | 0 / 52 |
Outcome results
Primary
Maximum Pain Score Over Study Period
reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain
Time frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Maximum Pain Score Over Study Period | 5.0 units on a scale | Standard Deviation 2.6 |
| Placebo | Maximum Pain Score Over Study Period | 5.5 units on a scale | Standard Deviation 2.2 |
p-value: 0.32t-test, 2 sided
Secondary
Number of Ibuprofen 800mg Tablets Used
summed number of tablets used by each participant over the 72 hour study period
Time frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin | Number of Ibuprofen 800mg Tablets Used | 1 tablets |
| Placebo | Number of Ibuprofen 800mg Tablets Used | 2 tablets |
Secondary
Number of Oxycodone/Acetominophen Tablets (5/325mg) Used
summed number of tablets used by each participant over the 72 hour study period
Time frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin | Number of Oxycodone/Acetominophen Tablets (5/325mg) Used | 0 tablets |
| Placebo | Number of Oxycodone/Acetominophen Tablets (5/325mg) Used | 0.5 tablets |
Secondary
Number of Participants Ever Experiencing Different Symptoms During Abortion
A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events.
Time frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants Ever Experiencing Different Symptoms During Abortion | Vomiting | 28 participants |
| Pregabalin | Number of Participants Ever Experiencing Different Symptoms During Abortion | Blurred Vision | 15 participants |
| Pregabalin | Number of Participants Ever Experiencing Different Symptoms During Abortion | Dizziness | 45 participants |
| Pregabalin | Number of Participants Ever Experiencing Different Symptoms During Abortion | Diarrhea | 28 participants |
| Pregabalin | Number of Participants Ever Experiencing Different Symptoms During Abortion | Sleepiness | 47 participants |
| Pregabalin | Number of Participants Ever Experiencing Different Symptoms During Abortion | Constipation | 6 participants |
| Pregabalin | Number of Participants Ever Experiencing Different Symptoms During Abortion | Headache | 28 participants |
| Pregabalin | Number of Participants Ever Experiencing Different Symptoms During Abortion | Dry Mouth | 22 participants |
| Pregabalin | Number of Participants Ever Experiencing Different Symptoms During Abortion | Nausea | 43 participants |
| Placebo | Number of Participants Ever Experiencing Different Symptoms During Abortion | Dry Mouth | 25 participants |
| Placebo | Number of Participants Ever Experiencing Different Symptoms During Abortion | Nausea | 42 participants |
| Placebo | Number of Participants Ever Experiencing Different Symptoms During Abortion | Vomiting | 30 participants |
| Placebo | Number of Participants Ever Experiencing Different Symptoms During Abortion | Sleepiness | 39 participants |
| Placebo | Number of Participants Ever Experiencing Different Symptoms During Abortion | Dizziness | 26 participants |
| Placebo | Number of Participants Ever Experiencing Different Symptoms During Abortion | Headache | 17 participants |
| Placebo | Number of Participants Ever Experiencing Different Symptoms During Abortion | Blurred Vision | 7 participants |
| Placebo | Number of Participants Ever Experiencing Different Symptoms During Abortion | Diarrhea | 29 participants |
| Placebo | Number of Participants Ever Experiencing Different Symptoms During Abortion | Constipation | 15 participants |
Secondary
Satisfaction With Analgesia
5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)
Time frame: Asked at time point of 24 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pregabalin | Satisfaction With Analgesia | Very dissatisfied | 2 Participants |
| Pregabalin | Satisfaction With Analgesia | Dissatisfied | 3 Participants |
| Pregabalin | Satisfaction With Analgesia | Neutral | 12 Participants |
| Pregabalin | Satisfaction With Analgesia | Satisfied | 11 Participants |
| Pregabalin | Satisfaction With Analgesia | Very satisfied | 25 Participants |
| Pregabalin | Satisfaction With Analgesia | No response | 2 Participants |
| Placebo | Satisfaction With Analgesia | Very satisfied | 11 Participants |
| Placebo | Satisfaction With Analgesia | Very dissatisfied | 3 Participants |
| Placebo | Satisfaction With Analgesia | Satisfied | 24 Participants |
| Placebo | Satisfaction With Analgesia | Dissatisfied | 0 Participants |
| Placebo | Satisfaction With Analgesia | No response | 1 Participants |
| Placebo | Satisfaction With Analgesia | Neutral | 13 Participants |