Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

Not Applicable

Completed

• Conditions: Pain Uterus
• Interventions: Drug: placebo; Drug: Fentanyl

• Registration Number: NCT03057041
• Lead Sponsor: University of Hawaii

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-17
• Study Start: 2017-03-23
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

Inclusion Criteria

• Seeking office based uterine aspiration
• Gestational age at 14 weeks or less
• Age 14 years or older with parental consent to participate in this research study if 14-17 years old
• Able to read, speak, and understand English
• Ability to understand materials and consent forms

Exclusion Criteria

• Seeking medical abortion, operating room based surgical abortion, or operating room based miscarriage management
• Gestational age greater than 14 weeks
• Age less than 14 years old
• Inability to read, speak, and understand English
• Current incarceration
• Weight less than 40kg
• Self-reported or documentation of significant cardiopulmonary disease
• Self-reported or documentation of alcohol or substance dependence or abuse
• Contraindications, relative contraindication to fentanyl use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Fentanyl	Fentanyl	-

Primary Outcome Measures

Name	Time	Method
Pain during uterine aspiration	During uterine aspiration or immediately after uterine aspiration	Self reported on 100 mm VAS

Secondary Outcome Measures

Name	Time	Method
Post-procedural pain	approximately 15 minutes after procedure end	Self reported on 100 mm VAS
Patient satisfaction with procedural pain control	approximately 15 minutes after procedure ends	Self reported on 100 mm VAS

Trial Locations

Locations (2)

Women's Options Center; 🇺🇸 Honolulu, Hawaii, United States

Planned Parenthood Columbia Willamette; 🇺🇸 Portland, Oregon, United States