Evaluation of Oral Midazolam in First-trimester Surgical Abortions

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Nausea; Anxiety; Pain

Treatments: Drug: Lidocaine; Drug: Ibuprofen; Drug: Midazolam; Other: Placebo-Cherry syrup

Study type: Interventional

Funder types: Other

Identifiers

NCT01830881

OHSU IRB 9064

Details and patient eligibility

About

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.

Full 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 medicine (lidocaine) near the cervix (PCB). The co-primary outcomes are patient perception of anxiety and pain with uterine aspiration reported on a 100 mm visual analogue scale (VAS). Secondary outcomes include reported anxiety and pain at time points before, during, and after the procedure, as well as subject satisfaction with anxiety and pain control and overall abortion experience. Due to the dose-dependent anterograde amnesic effect of midazolam, we will also investigate the effects on memory and recall, which has not previously been studied. In addition, we will also collect data on side effects frequently associated with oral midazolam such as nausea and sleepiness. Women will also be responsible for completing a one-page survey 1-3 days after the procedure visit and return it by mail using a pre-addressed and stamped envelope.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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))

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups, including a placebo group

placebo-cherry syrup and ibuprofen

Placebo Comparator group

Description:

5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine

Treatment:

Other: Placebo-Cherry syrup

Drug: Ibuprofen

Drug: Lidocaine

Midazolam and ibuprofen

Active Comparator group

Description:

5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine

Treatment:

Drug: Midazolam

Drug: Ibuprofen

Drug: Lidocaine