Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Uterus
• Intervention / Treatment: Drug: Fentanyl; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Women's Options Center
  • Oregon
    • Portland, Oregon, United States, 97212
      • Planned Parenthood Columbia Willamette

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; 1 mL of sterile saline in each nostril via mucosal atomizer 15 minutes prior to procedure start
Experimental: Fentanyl	Drug: Fentanyl; 100 mcg of intranasal fentanyl, 50 mcg/ mL in each nostril via mucosal atomizer 15 minutes prior to procedure start

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during uterine aspiration	Self reported on 100 mm VAS	During uterine aspiration or immediately after uterine aspiration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with procedural pain control	Self reported on 100 mm VAS	approximately 15 minutes after procedure ends
Post-procedural pain	Self reported on 100 mm VAS	approximately 15 minutes after procedure end

Collaborators and Investigators

• Sponsor: University of Hawaii
• Collaborators: Society of Family Planning

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No