Evaluation of Oral Midazolam in First-trimester Surgical Abortions

NCT ID: NCT01830881

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-01-31

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.

Conditions

Pain; Anxiety; Nausea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo-cherry syrup and ibuprofen

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

Group Type: PLACEBO_COMPARATOR

Ibuprofen

Intervention Type: DRUG

800 mg oral ibuprofen 30-60 minutes prior to procedure

Placebo-Cherry syrup

Intervention Type: OTHER

5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure

Lidocaine

Intervention Type: DRUG

injection of 20 mL 1% lidocaine without epinephrine

Midazolam and ibuprofen

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

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure

Ibuprofen

Intervention Type: DRUG

800 mg oral ibuprofen 30-60 minutes prior to procedure

Lidocaine

Intervention Type: DRUG

injection of 20 mL 1% lidocaine without epinephrine

Interventions

Midazolam

5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure

Intervention Type: DRUG

Ibuprofen

800 mg oral ibuprofen 30-60 minutes prior to procedure

Intervention Type: DRUG

Placebo-Cherry syrup

5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure

Intervention Type: OTHER

Lidocaine

injection of 20 mL 1% lidocaine without epinephrine

Intervention Type: DRUG

Other Intervention Names

Versed; Motrin; placebo cherry syrup; lidocaine injection

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))

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Lisa Bayer, MD MPH

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Bayer, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Planned Parenthood Columbia Willamette

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26241254 (View on PubMed)

Other Identifiers

OHSU IRB 9064

Identifier Type: -

Identifier Source: org_study_id