Pain
Conditions
Keywords
Pain during first trimester surgical abortion
Brief summary
The purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.
Detailed description
The investigators plan to conduct a double-blinded randomized placebo-controlled trial of 120 women undergoing elective first trimester surgical abortion. These women will be premedicated with either two tabs of 5/350 hydrocodone/acetaminophen or 2 tabs of a placebo. All subjects will receive ibuprofen and lorazepam preoperatively and a PCB. This study will examine the incremental benefit of HC/APAP over this standard medication regimen. Randomization will be stratified into two groups. Subjects less than 8 weeks gestation will comprise the early gestational age group. Subjects between 8 weeks 0 days and 10 weeks 6 days will comprise the late gestational age group. The investigators will be assessing patient perception of pain, nausea, satisfaction, and anxiety at multiple points during the clinic visit using 100-mm visual analogue scales (VAS).
Interventions
Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.
DRUGPlacebo
Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.
DRUGIbuprofen
800 mg oral ibuprofen
DRUGLorazepam
2 mg oral lorazepam
DRUGLidocaine
20 ml 1% buffered lidocaine, injected
Sponsors
Planned Parenthood Federation of America
Elizabeth Micks
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Voluntarily requesting surgical pregnancy termination * Pregnancy with intrauterine gestational sac up to 10 weeks 6 days gestation, dated by ultrasound * Eligible for suction curettage * English or Spanish speaking * Good general health * Able and willing to give informed consent and agree to terms of the study
Exclusion criteria
* Gestational ages 11 weeks or more * Incomplete abortion * Premedication with misoprostol * Use of any opioid medication within the past 7 days * Use of heroin within the past 7 days * Requested opioids or IV sedation prior to start of the procedure * Patients who refuse ibuprofen or lorazepam * Contraindications or allergies to HC/APAP, lidocaine, ibuprofen, or lorazepam * Significant medical problem necessitating inpatient procedure * Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease * Known hepatic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perception of Pain | At time of uterine aspiration (baseline) | To determine whether HC/APAP, given in addition to a standard regimen of ibuprofen, lorazepam, and PCB, affects patient pain perception at the time of uterine aspiration, as measured by distance (mm) from the left of the 100 mm visual analog scale (VAS). The number 0 indicates no pain, and 100 indicates worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perception of Pain During Cervical Dilation | During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting) | Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation |
| Satisfaction With Pain Control | 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration) | Distance (mm) from the left of the 100 mm VAS (VAS anchors: 0 = unsatisfied, 100 mm = very satisfied) recorded 30 minutes after completion of the procedure. |
| Postoperative Nausea | 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration) | To assess whether HC/APAP is associated with nausea, measured on the 100 mm VAS, recorded 30 minutes postoperatively. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable. |
| Need for Additional Intraoperative and/or Postoperative Pain Medication | 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration) | To assess need for additional intraoperative and/or postoperative pain medication |
Countries
United States
Participant flow
Recruitment details
Subjects in this study are women 18 years or older, recruited from OHSU and PPCW who present for an elective termination of pregnancy up to 10 weeks 6 days gestation
Participants by arm
| Arm | Count |
|---|---|
| Hydrocodone/Acetaminophen Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure. | 61 |
| Placebo Subject will receive placebo 45-90 minutes prior to abortion procedure. | 60 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | Hydrocodone/Acetaminophen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 60 Participants | 118 Participants |
| Age, Continuous | 24.7 years STANDARD_DEVIATION 4.5 | 26.1 years STANDARD_DEVIATION 6.3 | 25.4 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 60 participants | 61 participants | 121 participants |
| Sex: Female, Male Female | 60 Participants | 61 Participants | 121 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 | — / — | — / — |
| other Total, other adverse events | 2 / 61 | 1 / 60 |
| serious Total, serious adverse events | 1 / 61 | 1 / 60 |
Outcome results
Primary
Patient Perception of Pain
To determine whether HC/APAP, given in addition to a standard regimen of ibuprofen, lorazepam, and PCB, affects patient pain perception at the time of uterine aspiration, as measured by distance (mm) from the left of the 100 mm visual analog scale (VAS). The number 0 indicates no pain, and 100 indicates worst pain imaginable.
Time frame: At time of uterine aspiration (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrocodone/Acetaminophen | Patient Perception of Pain | 65.7 mm | Standard Deviation 25.4 |
| Placebo | Patient Perception of Pain | 63.1 mm | Standard Deviation 26.6 |
Secondary
Need for Additional Intraoperative and/or Postoperative Pain Medication
To assess need for additional intraoperative and/or postoperative pain medication
Time frame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydrocodone/Acetaminophen | Need for Additional Intraoperative and/or Postoperative Pain Medication | 0 Participants |
| Placebo | Need for Additional Intraoperative and/or Postoperative Pain Medication | 0 Participants |
Secondary
Patient Perception of Pain During Cervical Dilation
Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation
Time frame: During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrocodone/Acetaminophen | Patient Perception of Pain During Cervical Dilation | 47.2 mm | Standard Deviation 26.8 |
| Placebo | Patient Perception of Pain During Cervical Dilation | 43.9 mm | Standard Deviation 28.9 |
Secondary
Postoperative Nausea
To assess whether HC/APAP is associated with nausea, measured on the 100 mm VAS, recorded 30 minutes postoperatively. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable.
Time frame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrocodone/Acetaminophen | Postoperative Nausea | 19.4 mm | Standard Deviation 27 |
| Placebo | Postoperative Nausea | 11.4 mm | Standard Deviation 21.5 |
Secondary
Satisfaction With Pain Control
Distance (mm) from the left of the 100 mm VAS (VAS anchors: 0 = unsatisfied, 100 mm = very satisfied) recorded 30 minutes after completion of the procedure.
Time frame: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrocodone/Acetaminophen | Satisfaction With Pain Control | 74.8 mm | Standard Deviation 24.7 |
| Placebo | Satisfaction With Pain Control | 67.3 mm | Standard Deviation 24.7 |