CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 124 enrolled
Drug / intervention
Midazolam +3 moredrug
Likely dose
Midazolam 5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01830881
NCT01830881Phase 4Completed
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An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial

Oregon Health and Science University·interventional·Posted Apr 12, 2013·Updated Jun 25, 2018

In Brief

A Phase 4 clinical trial evaluating Midazolam, Ibuprofen, and 2 other interventions for Pain and 2 related conditions. Completed, enrolled 124 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Anxiety, Nausea
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2013
Enrollment StartApr 1, 2013
Primary CompletionDec 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.2 years ago

Interventions

Midazolamdrug

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

Ibuprofendrug

800 mg oral ibuprofen 30-60 minutes prior to procedure

Placebo-Cherry syrupother

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

Lidocainedrug

injection of 20 mL 1% lidocaine without epinephrine