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OpenTrials
Completed

NCT Number: NCT03057041

Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

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.

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Key information

Conditions

Pain Uterus

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Options Center, Honolulu, Hawaii, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Pain during uterine aspiration

    Time frame: During uterine aspiration or immediately after uterine aspiration

    Self reported on 100 mm VAS

Secondary outcomes

  1. Patient satisfaction with procedural pain control

    Time frame: approximately 15 minutes after procedure ends

    Self reported on 100 mm VAS

  2. Post-procedural pain

    Time frame: approximately 15 minutes after procedure end

    Self reported on 100 mm VAS

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 17, 2017
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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