Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

Pain Uterus Clinical Trial

Official title:

Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057041
• Other study ID #: INF
• Status: Completed
• Phase: N/A
• Start date: March 23, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: June 2018
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Uterus

Intervention

Drug:
• Fentanyl
100 mcg of intranasal fentanyl, 50 mcg/ mL in each nostril via mucosal atomizer 15 minutes prior to procedure start
• placebo
1 mL of sterile saline in each nostril via mucosal atomizer 15 minutes prior to procedure start

Locations

Country	Name	City	State
United States	Women's Options Center	Honolulu	Hawaii
United States	Planned Parenthood Columbia Willamette	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during uterine aspiration	Self reported on 100 mm VAS	During uterine aspiration or immediately after uterine aspiration
Secondary	Patient satisfaction with procedural pain control	Self reported on 100 mm VAS	approximately 15 minutes after procedure ends
Secondary	Post-procedural pain	Self reported on 100 mm VAS	approximately 15 minutes after procedure end