NCT03057041

Completed

Intranasal Fentanyl for Pain Control During First-Trimester ...

University of Hawaii Source

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Other study identifiers

Sponsor study identifier

INF

Study Type

interventional

Actual enrollment (reported)

107

Locations

1 country

Sites

2

Timeline

Study Start

March 23, 2017

Actual (reported)

Primary Completion

May 30, 2018

Actual (reported)

Study Completion

May 30, 2018

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 107 participants
Study completion date: May 30, 2018
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 14, 2017
Actual (reported)
First Posted
February 17, 2017
Actual (reported)
Study Start
March 23, 2017
Actual (reported)
Primary Completion
May 30, 2018
Actual (reported)
Study Completion
May 30, 2018
Actual (reported)

Last Updated: June 13, 2018
Status Verified: June 2018
Last Update Submitted: June 12, 2018

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

FentanylDrug

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

Fentanyl

placeboDrug

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

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age14 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Seeking office based uterine aspiration
Gestational age at 14 weeks or less

Sponsors & Collaborators

Society of Family Planning
Othercollaborator
University of Hawaii
Otherlead

Study Sites (2)

Women's Options Center

Honolulu, Hawaii, 96826, United States

Planned Parenthood Columbia Willamette

Portland, Oregon, 97212, United States

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Enrollment

107 participants (actual enrollment reported by the registry).

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

Actual (reported)

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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

Contact the study team to confirm eligibility.

Primary Completion

May 30, 2018

Actual (reported)

Study Completion

May 30, 2018

Actual (reported)

Last Updated

June 13, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03057041
Data provider: ClinicalTrials.gov
Source updated: 2018-06-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:11 UTC

Locations

US(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Fentanyl

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations