Evaluation of Oral Midazolam in First-trimester Surgical Abortions

Completed · Phase 4 · Has a placebo group

Conditions studied: Pain, Anxiety, Nausea

In brief

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.

Key facts

Study ID

NCT01830881

Run by

Oregon Health and Science University

People needed

124

Starts

2013-04-01

Expected to finish

2014-01-01

Last updated by the study team

2018-06-25

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• - 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))

Where it is running

• Planned Parenthood Columbia Willamette — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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