MedTrace Logo

Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

NCT03057041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2018-06-13

No results posted yet for this study

Summary

Intranasal fentanyl has been found to be safe and effective in the reduction of pain among pediatric and adult populations. The investigators hypothesize that patients who receive 100 mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will report lower pain scores than those who receive placebo. The investigators will test this hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain reported during uterine aspiration between patients who receive either intranasal fentanyl or intranasal saline prior to the procedure.

Conditions

  • Pain Uterus

Interventions

DRUG

Fentanyl

100 mcg of intranasal fentanyl, 50 mcg/ mL in each nostril via mucosal atomizer 15 minutes prior to procedure start

DRUG

placebo

1 mL of sterile saline in each nostril via mucosal atomizer 15 minutes prior to procedure start

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2018-05-30
Completion
2018-05-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03057041 on ClinicalTrials.gov