Phase 4
N=121
Hydrocodone For Pain Control in First Trimester Surgical Abortion
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01330459 ↗Enrolled (actual)
121
Serious AEs
1.7%
Results posted
Apr 2019
Primary outcome: Primary: Patient Perception of Pain — 65.7; 63.1 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydrocodone/acetaminophen (Drug); Placebo (Drug); Ibuprofen (Drug); Lorazepam (Drug); Lidocaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Elizabeth Micks
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Perception of Pain |
65.7; 63.1 | — |
| SECONDARY Patient Perception of Pain During Cervical Dilation |
47.2; 43.9 | — |
| SECONDARY Satisfaction With Pain Control |
74.8; 67.3 | — |
| SECONDARY Postoperative Nausea |
19.4; 11.4 | — |
| SECONDARY Need for Additional Intraoperative and/or Postoperative Pain Medication |
0; 0 | — |
Summary
The purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01330459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.