Evaluation of Oral Midazolam in First-trimester Surgical Abortions
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/27/2018 |
| Start Date: | April 2013 |
| End Date: | January 2014 |
An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial
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.
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.
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.
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.
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))
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