Phase 4
N=124
Evaluation of Oral Midazolam in First-trimester Surgical Abortions
Pain · Anxiety · Nausea
Bottom Line
View on ClinicalTrials.gov: NCT01830881 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Subject Perception of Pain and Anxiety During Uterine Aspiration — 74.3; 70.1; 68.2; 60.9 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Midazolam (Drug); Ibuprofen (Drug); Placebo-Cherry syrup (Other); Lidocaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Oregon Health and Science University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Perception of Pain and Anxiety During Uterine Aspiration |
74.3; 70.1; 68.2; 60.9 | — |
| SECONDARY Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline |
77.5; 74.2; 67.2; 69.2 | — |
| SECONDARY Subject Perception of Pain and Anxiety Upon Entering Procedure Room |
51.4; 34.5; 17.5; 10.1 | — |
| SECONDARY Subject Perception of Pain and Anxiety Post Procedure |
20.9; 14.4; 34.7; 37.1 | — |
| SECONDARY Subject Perception of Anxiety With Patient Positioning Procedure |
56.6; 45.4 | — |
| SECONDARY Subject Perception of Pain During Cervical Dilation |
73.0; 69.3 | — |
| SECONDARY State-Trait Anxiety Inventory for Anxiety at Baseline |
50.8; 51.3; 40.1; 38.6 | — |
| SECONDARY Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively |
56.1; 68.9; 43.2; 50.0 | — |
| SECONDARY Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure |
50.2; 64.7; 36.6; 48.2 | — |
| SECONDARY Subject Extent of Amnesia Using Amnesia Score |
16; 31; 45; 30 | — |
| SECONDARY Subject Extent of Amnesia |
91.5; 61.3 | — |
| SECONDARY Subject Extent of Sedation |
11; 10; 50; 51; 0; 1 | — |
| SECONDARY Subject Vital Signs (Heart Rate) |
80; 78.5 | — |
| SECONDARY Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure |
70.1; 72 | — |
| SECONDARY Subject Nausea 30 Minutes Postprocedure |
9.5; 3.5 | — |
| SECONDARY Subject's Correct Identification of Receiving Midazolam or Placebo |
43; 48 | — |
| SECONDARY Subject Vital Signs (Oxygenation Saturation) |
98.3; 98.1 | — |
| SECONDARY Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure |
98.3; 98.1 | — |
| SECONDARY Subject Sleepiness 30 Minutes Postprocedure |
40.1; 56.6 | — |
| SECONDARY Number of Participants With Need for Additional Postoperative Pain Medication |
3; 2; 2; 1 | — |
Summary
The purpose of this study is to determine the level of pain, anxiety and side effects that women experience with a surgical abortion and the effect that the anti-anxiety medication, midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead of the standard pain treatment of only ibuprofen and a PCB.
Eligibility Criteria
Inclusion Criteria
- Aged 18 years or older
- Voluntarily requesting surgical pregnancy termination
- Pregnancy with intrauterine gestational sac between 6 0/7 and 10 6/7 weeks gestation, dated by ultrasound
- Eligible for suction aspiration
- English or Spanish speaking
- Good general health
- Able and willing to give informed consent and agree to terms of the study
- Have assistance home; no driving for 24 hours
Exclusion Criteria
- - Gestational ages 11 0/7 weeks or more
- Gestational age less than 6 0/7 weeks
- Incomplete abortion
- Premedication with misoprostol
- Use of narcotic pain or anti-anxiety medication within past 24 hours
- Use of heroin or methadone within last 3 months
- Chronic alcoholism or alcohol intoxication within past 24 hours
- Requested narcotics or Intravenous sedation (prior to randomization)
- Allergic reaction or allergy to cherry/cherry flavoring or lidocaine or non-steroidal anti-inflammatory drugs (NSAIDs)
- Allergic reaction or sensitivity to benzodiazepines including hyperactive or aggressive behavior (paradoxical reaction)
- Medical problem necessitating inpatient procedure
- Untreated acute cervicitis or pelvic inflammatory disease
- Known acute narrow-angle glaucoma
- Weighing less than 100 lb (45 kg)
- Use of potent medications interfering with microsomal metabolism within past 48 hours (carbamazepine (Tegretol), cimetidine (Tagamet), diltiazem (Cardizem), erythromycin, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), phenobarbital, phenytoin (Dilantin), nelfinavir, ranitidine (Zantac), rifampin (Rifadin), ritonavir (Norvir), saquinavir, verapamil (Calan))
Data sourced from ClinicalTrials.gov (NCT01830881). 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.