Evaluation of Oral Midazolam in First-trimester Surgical Abortions
Condition: Pain; Anxiety; Nausea
MeSH terms: Anxiety Disorders
Intervention: Midazolam; Ibuprofen; Placebo-Cherry syrup; Lidocaine
Intervention description: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure; 800 mg oral ibuprofen 30-60 minutes prior to procedure; 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure; injection of 20 mL 1% lidocaine without epinephrine
Intervention MeSH terms: Ibuprofen; Lidocaine; Midazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pain; anxiety; surgical abortion; midazolam; benzodiazepine

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))