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Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057041
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of Hawaii

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Uterus Drug: Fentanyl Drug: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration: A Randomized Controlled Trial
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

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


Outcome Measures
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Primary Outcome Measures :
  1. Pain during uterine aspiration [ Time Frame: During uterine aspiration or immediately after uterine aspiration ]
    Self reported on 100 mm VAS


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057041


Locations
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United States, Hawaii
Women's Options Center
Honolulu, Hawaii, United States, 96826
United States, Oregon
Planned Parenthood Columbia Willamette
Portland, Oregon, United States, 97212
Sponsors and Collaborators
University of Hawaii
Society of Family Planning
More Information
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Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT03057041    
Other Study ID Numbers: INF
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics