Status:
COMPLETED
Evaluation of Oral Midazolam in First-trimester Surgical Abortions
Lead Sponsor:
Oregon Health and Science University
Conditions:
Pain
Anxiety
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief 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 h...
Detailed Description
Women in the study will be randomized to receive either midazolam or placebo. Every participant will still receive the standard oral medications for pain (ibuprofen) as well as an injection of numbing...
Eligibility Criteria
Inclusion
- 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
- \- 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))
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01830881
Start Date
April 1 2013
End Date
January 1 2014
Last Update
June 25 2018
Active Locations (1)
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1
Planned Parenthood Columbia Willamette
Portland, Oregon, United States, 97206