NCT01830881

Evaluation of Oral Midazolam in First-trimester Surgical Abortions

An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Midazolam	5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
DRUG	Ibuprofen	800 mg oral ibuprofen 30-60 minutes prior to procedure
OTHER	Placebo-Cherry syrup	5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
DRUG	Lidocaine	injection of 20 mL 1% lidocaine without epinephrine

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2013-04-12
• Last updated: 2018-06-25
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States