Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

NCT ID: NCT03057041

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-23
• Study Completion Date: 2018-05-30

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.

Conditions

Pain Uterus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fentanyl

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

Fentanyl

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Women's Options Center

Honolulu, Hawaii, United States

Planned Parenthood Columbia Willamette

Portland, Oregon, United States

Countries

United States

Other Identifiers

INF

Identifier Type: -

Identifier Source: org_study_id