Clinical trial NCT01830881: Evaluation of Oral Midazolam in First-trimester Surgical Abortions
Official title: An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Anxiety
Nausea
Keywords: pain
anxiety
surgical abortion
midazolam
benzodiazepine
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 have when used along with ibuprofen and a paracervical block (PCB) instead of the standard pain treatment of only ibuprofen and a PCB.

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 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.

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))

Primary outcomes:
measure: Subject Perception of Pain and Anxiety During Uterine Aspiration
timeFrame: at time of uterine aspiration (30-60 minutes after premedication)
Secondary outcomes:
measure: Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline
timeFrame: Baseline (upon entry into study)
measure: Subject Perception of Pain and Anxiety Upon Entering Procedure Room
timeFrame: upon entering procedure room (30-60 minutes after premedication)
measure: Subject Perception of Pain and Anxiety Post Procedure
timeFrame: 30 minutes post operatively
measure: Subject Perception of Anxiety With Patient Positioning Procedure
timeFrame: prior to starting pelvic exam (30-60 minutes after premedication)
measure: Subject Perception of Pain During Cervical Dilation
timeFrame: with cervical dilation (30-60 minutes after premedication)
measure: State-Trait Anxiety Inventory for Anxiety at Baseline
timeFrame: Baseline (upon entry into study)
measure: Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively
timeFrame: 30 minutes post-operatively
measure: Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure
timeFrame: 1-3 days post-operatively
measure: Subject Extent of Amnesia Using Amnesia Score
timeFrame: 30 minutes postoperatively
measure: Subject Extent of Amnesia
timeFrame: 1-3 days postoperatively
measure: Subject Extent of Sedation
timeFrame: 30-60 minutes after premedication
measure: Subject Vital Signs (Heart Rate)
timeFrame: intraoperatively (30-60 minutes after premedication)
measure: Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure
timeFrame: 30 minutes postoperatively
measure: Subject Nausea 30 Minutes Postprocedure
timeFrame: 30 minutes postoperatively
measure: Subject's Correct Identification of Receiving Midazolam or Placebo
timeFrame: 30 minutes postoperatively
measure: Subject Vital Signs (Oxygenation Saturation)
timeFrame: intraoperatively (30-60 minutes after premedication)
measure: Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure
timeFrame: 30 minutes postoperatively
measure: Subject Sleepiness 30 Minutes Postprocedure
timeFrame: 30 minutes postoperatively
measure: Number of Participants With Need for Additional Postoperative Pain Medication
timeFrame: 30 minutes postoperatively
Other outcomes:
Locations:
city: Portland
country: United States
facility: Planned Parenthood Columbia Willamette
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Lisa Bayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bayer LL, Edelman AB, Fu R, Lambert WE, Nichols MD, Bednarek PH, Miller K, Jensen JT. An Evaluation of Oral Midazolam for Anxiety and Pain in First-Trimester Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):37-46. doi: 10.1097/AOG.0000000000000913.