Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

Completed · Not applicable · Has a placebo group

Conditions studied: Pain Uterus

In brief

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.

Key facts

Study ID

NCT03057041

Run by

University of Hawaii

People needed

107

Starts

2017-03-23

Expected to finish

2018-05-30

Last updated by the study team

2018-06-13

Who can join

Age: 14 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Women's Options Center — Honolulu, Hawaii, United States
• Planned Parenthood Columbia Willamette — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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