Pain, AcutePhase 3FINDOLNCT03063359
Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma
A Phase 3 study of Pain, Acute, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments. To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Pain, Acute
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2017to 12 Mar 2019
- Phase
- Phase 3
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient aged between 4 years old and 15,3 years old
- Acute pain in traumatic context with a suspicion of fracture for patient <7years old : feeling Pain >6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not <10 points)
- For patients >7 years old : feeling pain >6 points and defined thanks to a visual analogic scale
- Informed consent form signed by parents
- Beneficiary of an european health protection
Who cannot join
- Antalgic ( II or III) within 4 hours before the inclusion
- Allergic or non-indication of fentanyl
- Allergic or contraindication of morphine sulfate
- Pre existing peripheral intravenous catheter
- Traumatic brain injury
- Nasal traumatic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-inferiority of Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma : a Controled Randomized , Single Blind Study
Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments.
To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it.
The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department.
- Conditions
- Pain, Acute
- Being tested
- Intranasal fentanyl + Oral Placebo, Oral Morphine + Intranasal Placebo
- Keywords
- traumatic pain, children, fentanyl, intranasal use
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal fentanyl + Oral PlaceboDrug
Also called Intranasal Fentanyl + Oral NaCl
Administration of intranasal fentanyl (1.5µg/kg) and Oral placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.
Oral Morphine + Intranasal PlaceboDrug
Also called Oral Morphine + Intranasal NaCl
Administration of oral morphine (0,4mg/kg) and intranasal placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal fentanyl + Oral placebo | Experimental | Administration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department. Receives: Drug: Intranasal fentanyl + Oral Placebo |
| Oral morphine + Intranasal placebo | Active comparator | Administration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department. Receives: Drug: Oral Morphine + Intranasal Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the value of the pain feeling
Assessment of the value of the pain feeling measured by visual analogic scale
Measured: 45 minutes
Secondary outcomes (1)
Delay in treatment efficacy
Delay in treatment efficacy measured by a reduction of pain (1 point) assessed by visual analogic scale from the administration of the treatement.
Measured: up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start30 May 2017
- Primary completion18 Jul 2018
- Study completion12 Mar 2019
Why it stopped: The new pain protocols imposed by the HAS make it difficult to include new patients in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaël GG GUYON, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063359
- Sponsor's protocol ID
- 9732
- Acronym
- FINDOL
- Status last verified
- Dec 2020
- First submitted
- 30 Jan 2017
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority of Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma : a Controled Randomized , Single Blind Study
- ClinicalTrials.gov ID
- NCT03063359
- Acronym / sponsor ID
- FINDOL / 9732
- Conditions
- Pain, Acute
- Keywords
- traumatic pain, children, fentanyl, intranasal use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The new pain protocols imposed by the HAS make it difficult to include new patients in the study
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 24 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.
Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments.
To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it.
The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal fentanyl + Oral placebo | Experimental | Drug: Intranasal fentanyl + Oral PlaceboAdministration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department. |
| Oral morphine + Intranasal placebo | Active comparator | Drug: Oral Morphine + Intranasal PlaceboAdministration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patient aged between 4 years old and 15,3 years old
- Acute pain in traumatic context with a suspicion of fracture for patient <7years old : feeling Pain >6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not <10 points)
- For patients >7 years old : feeling pain >6 points and defined thanks to a visual analogic scale
- Informed consent form signed by parents
- Beneficiary of an european health protection
Key exclusion criteria (6 listed)
- Antalgic ( II or III) within 4 hours before the inclusion
- Allergic or non-indication of fentanyl
- Allergic or contraindication of morphine sulfate
- Pre existing peripheral intravenous catheter
- Traumatic brain injury
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 |
|---|---|---|
| Intranasal fentanyl + Oral PlaceboAlso: Intranasal Fentanyl + Oral NaClAdministration of intranasal fentanyl (1.5µg/kg) and Oral placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department. | Drug | Intranasal fentanyl + Oral placebo |
| Oral Morphine + Intranasal PlaceboAlso: Oral Morphine + Intranasal NaClAdministration of oral morphine (0,4mg/kg) and intranasal placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department. | Drug | Oral morphine + Intranasal placebo |
Primary outcome
Assessment of the value of the pain feeling
Time frame: 45 minutes
Assessment of the value of the pain feeling measured by visual analogic scale
1 secondary outcome
Delay in treatment efficacy
Time frame: up to 45 minutes
Results and safety
The study was stopped early (reason given: The new pain protocols imposed by the HAS make it difficult to include new patients in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Pain, Acute
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
Gaël GG GUYON, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Pain, Acute, run by University Hospital, Montpellier at 1 site in France.
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 6 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: stopped early, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The new pain protocols imposed by the HAS make it difficult to include new patients in the study). Results are not available in the source record.
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?
Assessment of the value of the pain feeling (time frame: 45 minutes). 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 31 Dec 2020.