Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

• Status: Completed
• Trial end date: 2018-05-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Hawaii
• Collaborator: Society of Family Planning
• Treatments: Fentanyl

Criteria

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