Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

NCT03057041 | Completed

• 1 other identifier: INF
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Pain during uterine aspiration

  Self reported on 100 mm VAS

  During uterine aspiration or immediately after uterine aspiration

Secondary Outcomes (2)

• Patient satisfaction with procedural pain control

  approximately 15 minutes after procedure ends

• Post-procedural pain

  approximately 15 minutes after procedure end

Study Arms (2)

Fentanyl

EXPERIMENTAL

Drug: Fentanyl

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Fentanyl DRUG

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

Fentanyl

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Hawaii: lead
• Society of Family Planning: collaborator

Study Sites (2)

Women's Options Center

Honolulu, Hawaii, 96826, United States

Location

Planned Parenthood Columbia Willamette

Portland, Oregon, 97212, United States

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 17, 2017
• Study Start: March 23, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)