Inhalation of Nitrous OxidePhase 3NCT02533908
Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children
A Phase 3 study testing Fentanyl intranasal and NaCl 0.9% intranasal in people with Inhalation of Nitrous Oxide and Opioid Analgesic Adverse Reaction, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for analgosedation for short and painful procedures in children. Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Inhalation of Nitrous Oxide, Opioid Analgesic Adverse Reaction, Pain
- What is being tested?
- Fentanyl intranasal and NaCl 0.9% intranasal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Sep 2015to 12 Oct 2017
- 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 2 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- indication for nitrous oxide 70% application
- boys/girls aged 2-16 years
- informed consent
Who cannot join
- due to language barrier no sufficient communication possible to explain the study
- incompatibility to Fentanyl Sintetica
- incompatibility to morphinomimetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children: A Prospective, Randomized, Double-blind, Placebo-controlled, Monocentric Study
This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for analgosedation for short and painful procedures in children.
Read the detailed description
Nitrous oxide 70% (N20 70%) combined with 30% oxygen meets many criteria of an ideal pain medication for procedural analgosedation in children. At the emergency department of the Children's Hospital of Zurich, Switzerland, N20 70% is regularly used for short and painful orthopaedic procedures, mostly for reduction of dislocated forearm or finger fractures. The analgesic efficacy of N20 70% still remains controversial. Therefore, all children who are eligible for N20 70% receive additionally either fentanyl or placebo intranasal and then their behavior, level of sedation and adverse events are measured during the painful procedure. The hypothesis is that a combination of N20 70% and fentanyl intranasal is not significant better than N20 70% combined with basic analgetics.
- Being tested
- Fentanyl intranasal, NaCl 0.9% intranasal
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl intranasalDrug
Also called Fentanyl Sintetica
fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation
NaCl 0.9% intranasalDrug
Also called NaCl 0.9% Sintetica
Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl intranasal | Active comparator | Fentanyl Sintetica 0.1mg/2ml: 1.5ug/kilogram intranasal= 0.03ml/kg once Receives: Drug: Fentanyl intranasal |
| NaCl 0.9% intranasal | Placebo comparator | NaCl 0.9% Sintetica 18mg/2ml: same dosage as fentanyl= 0.03ml/kg Receives: Drug: NaCl 0.9% intranasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficacy of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal using the FLACC score
the Patient is videotaped during the painful procedure and afterwards the video is analysed using the FLACC score. Each category is scored on a 0-2 scale (5 categories) which results in a total score of 0 (no pain) -10 (severe pain).
Measured: up to 18 months
Secondary outcomes (1)
adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start21 Sep 2015
- Primary completion12 Oct 2017
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inhalation of Nitrous OxideStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Seiler, Principal investigator, University Children's Hospital of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533908
- Sponsor's protocol ID
- Fentanyl-2015
- Status last verified
- Oct 2016
- First submitted
- 20 Jul 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Seiler M, Staubli G, Landolt MA. Combined nitrous oxide 70% with intranasal fentanyl for procedural analgosedation in children: a prospective, randomised, double-blind, placebo-controlled trial. Emerg Med J. 2019 Mar;36(3):142-147. doi: 10.1136/emermed-2018-207892. Epub 2019 Jan 10.
PubMed 30630844
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children: A Prospective, Randomized, Double-blind, Placebo-controlled, Monocentric Study
- ClinicalTrials.gov ID
- NCT02533908
- Acronym / sponsor ID
- Fentanyl-2015
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 21 Sep 2015
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 27 Aug 2015 (estimated)
- 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.
This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for analgosedation for short and painful procedures in children.
Detailed description
Nitrous oxide 70% (N20 70%) combined with 30% oxygen meets many criteria of an ideal pain medication for procedural analgosedation in children. At the emergency department of the Children's Hospital of Zurich, Switzerland, N20 70% is regularly used for short and painful orthopaedic procedures, mostly for reduction of dislocated forearm or finger fractures. The analgesic efficacy of N20 70% still remains controversial. Therefore, all children who are eligible for N20 70% receive additionally either fentanyl or placebo intranasal and then their behavior, level of sedation and adverse events are measured during the painful procedure. The hypothesis is that a combination of N20 70% and fentanyl intranasal is not significant better than N20 70% combined with basic analgetics.
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 intranasal | Active comparator | Drug: Fentanyl intranasalFentanyl Sintetica 0.1mg/2ml: 1.5ug/kilogram intranasal= 0.03ml/kg once |
| NaCl 0.9% intranasal | Placebo comparator | Drug: NaCl 0.9% intranasalNaCl 0.9% Sintetica 18mg/2ml: same dosage as fentanyl= 0.03ml/kg |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- indication for nitrous oxide 70% application
- boys/girls aged 2-16 years
- informed consent
Key exclusion criteria (3 listed)
- due to language barrier no sufficient communication possible to explain the study
- incompatibility to Fentanyl Sintetica
- incompatibility to morphinomimetics
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 |
|---|---|---|
| Fentanyl intranasalAlso: Fentanyl Sinteticafentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation | Drug | Fentanyl intranasal |
| NaCl 0.9% intranasalAlso: NaCl 0.9% SinteticaPlacebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation | Drug | NaCl 0.9% intranasal |
Primary outcome
Analgesic efficacy of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal using the FLACC score
Time frame: up to 18 months
the Patient is videotaped during the painful procedure and afterwards the video is analysed using the FLACC score. Each category is scored on a 0-2 scale (5 categories) which results in a total score of 0 (no pain) -10 (severe pain).
1 secondary outcome
adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal
Time frame: up to 18 months
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 26 Oct 2017.
- Derived from this study: PubMed 30630844Seiler M, Staubli G, Landolt MA. Combined nitrous oxide 70% with intranasal fentanyl for procedural analgosedation in children: a prospective, randomised, double-blind, placebo-controlled trial. Emerg Med J. 2019 Mar;36(3):142-147. doi: 10.1136/emermed-2018-207892. Epub 2019 Jan 10.
- 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.
Michelle Seiler principal investigator
University Children's Hospital of Zurich
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 testing Fentanyl intranasal and NaCl 0.9% intranasal in people with Inhalation of Nitrous Oxide and Opioid Analgesic Adverse Reaction, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 3 inclusion and 3 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 26 Oct 2017. 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 Switzerland. 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.
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 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?
Analgesic efficacy of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal using the FLACC score (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533908, which also lists 1 linked publication.
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 26 Oct 2017.