Pain UterusNCT03057041
Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration
A study testing Fentanyl in people with Pain Uterus, run by University of Hawaii at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Uterus
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Mar 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Women's Options Center
Honolulu, Hawaii, 96826
Planned Parenthood Columbia Willamette
Portland, Oregon, 97212
About this study
Official title: 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.
- Conditions
- Pain Uterus
- Being tested
- Fentanyl, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
100 mcg of intranasal fentanyl, 50 mcg/ mL in each nostril via mucosal atomizer 15 minutes prior to procedure start
placeboDrug
1 mL of sterile saline in each nostril via mucosal atomizer 15 minutes prior to procedure start
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Experimental | Not described Receives: Drug: Fentanyl |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during uterine aspiration
Self reported on 100 mm VAS
Measured: During uterine aspiration or immediately after uterine aspiration
Secondary outcomes (2)
Patient satisfaction with procedural pain control
Self reported on 100 mm VAS
Measured: approximately 15 minutes after procedure ends
Post-procedural pain
Self reported on 100 mm VAS
Measured: approximately 15 minutes after procedure end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start23 Mar 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain UterusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057041
- Sponsor's protocol ID
- INF
- Status last verified
- Jun 2018
- First submitted
- 14 Feb 2017
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03057041
- Acronym / sponsor ID
- INF
- Conditions
- Pain Uterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: Fentanyl |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl100 mcg of intranasal fentanyl, 50 mcg/ mL in each nostril via mucosal atomizer 15 minutes prior to procedure start | Drug | Fentanyl |
| placebo1 mL of sterile saline in each nostril via mucosal atomizer 15 minutes prior to procedure start | Drug | Placebo |
Primary outcome
Pain during uterine aspiration
Time frame: During uterine aspiration or immediately after uterine aspiration
Self reported on 100 mm VAS
2 secondary outcomes
Patient satisfaction with procedural pain control
Time frame: approximately 15 minutes after procedure ends
Post-procedural pain
Time frame: approximately 15 minutes after procedure end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl in people with Pain Uterus, run by University of Hawaii at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during uterine aspiration (time frame: During uterine aspiration or immediately after uterine aspiration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.