Facial LacerationNCT04745260
Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Pediatric Facial Laceration Repair
A study testing Intranasal Fentanyl Spray and Intranasal Midazolam Spray and Intranasal Midazolam Spray in people with Facial Laceration and Anxiety, run by University of Texas at Austin.
Trial summary
The purpose of the study is to compare the effectiveness of a combination of intranasal fentanyl and intranasal midazolam to intranasal midazolam alone for analgesia and anxiolysis in patients presenting for facial laceration repair in the pediatric emergency department. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Laceration, Anxiety
- What is being tested?
- Intranasal Fentanyl Spray and Intranasal Midazolam Spray and Intranasal Midazolam Spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 31 Dec 2021
- 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 1 year to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Facial laceration requiring repair with sutures
- English or Spanish-speaking parent/guardian
Who cannot join
- Lacerations requiring IV sedation or subspecialist involvement
- Patient has other injuries requiring medical attention
- Patient has vital sign instability, per physician discretion
- Patient has autism spectrum disorder
- Patient has allergies to either medication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial of Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Analgesia and Anxiolysis During Pediatric Facial Laceration Repair
The purpose of the study is to compare the effectiveness of a combination of intranasal fentanyl and intranasal midazolam to intranasal midazolam alone for analgesia and anxiolysis in patients presenting for facial laceration repair in the pediatric emergency department.
Read the detailed description
This study will be a single blind (blinded observer) randomized control trial to evaluate the efficacy of the combination of intranasal fentanyl and intranasal midazolam compared to intranasal midazolam alone for analgesia and anxiolysis during pediatric facial laceration repair.
- Conditions
- Facial Laceration, Anxiety
- Being tested
- Intranasal Fentanyl Spray and Intranasal Midazolam Spray, Intranasal Midazolam Spray
- Keywords
- Laceration repair, Facial laceration, Anxiety, Midazolam, Fentanyl
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Fentanyl Spray and Intranasal Midazolam SprayDrug
Also called Versed
Intranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg
Intranasal Midazolam SprayDrug
Also called Versed
Intranasal Midazolam 0.3mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Midazolam and Intranasal Fentanyl | Experimental | Study participants assigned to the combination (experimental) group will receive a weight-based dose of intranasal Fentanyl (50mcg/mL concentration at 2mcg/kg up to 100mcg) followed by intranasal Midazolam (5mg/mL concentration at 0.2mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer). Receives: Drug: Intranasal Fentanyl Spray and Intranasal Midazolam Spray |
| Intranasal Midazolam | Active comparator | Study participants assigned to the control (active comparator) group will receive only intranasal Midazolam (5mg/mL concentration at 0.3mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer). Receives: Drug: Intranasal Midazolam Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Yale Preoperative Anxiety Score (mYPAS)
mYPAS score at time of positioning, to be completed by blinded researcher (provider) to assess anxiety level. Scores range from 22.5 to 100, with higher scores indicating greater anxiety.
Measured: Pre-procedure
Secondary outcomes (4)
Provider Satisfaction with Procedural Sedation (Visual Analog Score)
VAS (visual analog score) completed by blinded researcher (provider) to rate satisfaction with level of sedation and ease of procedure. The scale will range from 0 (unsatisfied) to 100 (very satisfied).
Measured: Immediately after the procedure
Parent Satisfaction with Anxiolysis (Visual Analog Scale)
VAS (visual analog score) completed by parent to rate satisfaction with level of anxiolysis for procedure. The scale will range from 0 (unsatisfied) to 100 (very satisfied).
Measured: Immediately after the procedure
Rate of Treatment Failure
Failure of intervention to provide appropriate anxiolysis and need for IV sedation
Measured: Immediately after the procedure
Duration of Procedure
Duration of procedure from positioning to last suture placement, to be recorded by blinded researcher (provider)
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Facial LacerationStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittany DiFabio, University of Texas at Austin
- Investigators
- Brittany J DiFabio, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745260
- Sponsor's protocol ID
- 2020040016
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fein JA, Zempsky WT, Cravero JP; Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine; American Academy of Pediatrics. Relief of pain and anxiety in pediatric patients in emergency medical systems. Pediatrics. 2012 Nov;130(5):e1391-405. doi: 10.1542/peds.2012-2536. Epub 2012 Oct 29.
PubMed 23109683Kennedy RM, Luhmann JD. The "ouchless emergency department". Getting closer: advances in decreasing distress during painful procedures in the emergency department. Pediatr Clin North Am. 1999 Dec;46(6):1215-47, vii-viii. doi: 10.1016/s0031-3955(05)70184-x.
PubMed 10629683Miller JL, Capino AC, Thomas A, Couloures K, Johnson PN. Sedation and Analgesia Using Medications Delivered via the Extravascular Route in Children Undergoing Laceration Repair. J Pediatr Pharmacol Ther. 2018 Mar-Apr;23(2):72-83. doi: 10.5863/1551-6776-23.2.72.
PubMed 29720907Ryan PM, Kienstra AJ, Cosgrove P, Vezzetti R, Wilkinson M. Safety and effectiveness of intranasal midazolam and fentanyl used in combination in the pediatric emergency department. Am J Emerg Med. 2019 Feb;37(2):237-240. doi: 10.1016/j.ajem.2018.05.036. Epub 2018 May 17.
PubMed 30146398Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
PubMed 9322455Kogan A, Katz J, Efrat R, Eidelman LA. Premedication with midazolam in young children: a comparison of four routes of administration. Paediatr Anaesth. 2002 Oct;12(8):685-9. doi: 10.1046/j.1460-9592.2002.00918.x.
PubMed 12472704Neville DN, Hayes KR, Ivan Y, McDowell ER, Pitetti RD. Double-blind Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department. Acad Emerg Med. 2016 Aug;23(8):910-7. doi: 10.1111/acem.12998.
PubMed 27129606
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Analgesia and Anxiolysis During Pediatric Facial Laceration Repair
- ClinicalTrials.gov ID
- NCT04745260
- Acronym / sponsor ID
- 2020040016
- Conditions
- Facial Laceration, Anxiety
- Keywords
- Laceration repair, Facial laceration, Anxiety, Midazolam, Fentanyl
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Feb 2021 (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.
The purpose of the study is to compare the effectiveness of a combination of intranasal fentanyl and intranasal midazolam to intranasal midazolam alone for analgesia and anxiolysis in patients presenting for facial laceration repair in the pediatric emergency department.
Detailed description
This study will be a single blind (blinded observer) randomized control trial to evaluate the efficacy of the combination of intranasal fentanyl and intranasal midazolam compared to intranasal midazolam alone for analgesia and anxiolysis during pediatric facial laceration repair.
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 |
|---|---|---|
| Intranasal Midazolam and Intranasal Fentanyl | Experimental | Drug: Intranasal Fentanyl Spray and Intranasal Midazolam SprayStudy participants assigned to the combination (experimental) group will receive a weight-based dose of intranasal Fentanyl (50mcg/mL concentration at 2mcg/kg up to 100mcg) followed by intranasal Midazolam (5mg/mL concentration at 0.2mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer). |
| Intranasal Midazolam | Active comparator | Drug: Intranasal Midazolam SprayStudy participants assigned to the control (active comparator) group will receive only intranasal Midazolam (5mg/mL concentration at 0.3mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer). |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Facial laceration requiring repair with sutures
- English or Spanish-speaking parent/guardian
Key exclusion criteria (5 listed)
- Lacerations requiring IV sedation or subspecialist involvement
- Patient has other injuries requiring medical attention
- Patient has vital sign instability, per physician discretion
- Patient has autism spectrum disorder
- Patient has allergies to either medication
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 Spray and Intranasal Midazolam SprayAlso: VersedIntranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg | Drug | Intranasal Midazolam and Intranasal Fentanyl |
| Intranasal Midazolam SprayAlso: VersedIntranasal Midazolam 0.3mg/kg | Drug | Intranasal Midazolam |
Primary outcome
Modified Yale Preoperative Anxiety Score (mYPAS)
Time frame: Pre-procedure
mYPAS score at time of positioning, to be completed by blinded researcher (provider) to assess anxiety level. Scores range from 22.5 to 100, with higher scores indicating greater anxiety.
4 secondary outcomes
Provider Satisfaction with Procedural Sedation (Visual Analog Score)
Time frame: Immediately after the procedure
Parent Satisfaction with Anxiolysis (Visual Analog Scale)
Time frame: Immediately after the procedure
Rate of Treatment Failure
Time frame: Immediately after the procedure
Duration of Procedure
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Background: PubMed 23109683Fein JA, Zempsky WT, Cravero JP; Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine; American Academy of Pediatrics. Relief of pain and anxiety in pediatric patients in emergency medical systems. Pediatrics. 2012 Nov;130(5):e1391-405. doi: 10.1542/peds.2012-2536. Epub 2012 Oct 29.
- Background: PubMed 10629683Kennedy RM, Luhmann JD. The "ouchless emergency department". Getting closer: advances in decreasing distress during painful procedures in the emergency department. Pediatr Clin North Am. 1999 Dec;46(6):1215-47, vii-viii. doi: 10.1016/s0031-3955(05)70184-x.
- Background: PubMed 29720907Miller JL, Capino AC, Thomas A, Couloures K, Johnson PN. Sedation and Analgesia Using Medications Delivered via the Extravascular Route in Children Undergoing Laceration Repair. J Pediatr Pharmacol Ther. 2018 Mar-Apr;23(2):72-83. doi: 10.5863/1551-6776-23.2.72.
- Background: PubMed 30146398Ryan PM, Kienstra AJ, Cosgrove P, Vezzetti R, Wilkinson M. Safety and effectiveness of intranasal midazolam and fentanyl used in combination in the pediatric emergency department. Am J Emerg Med. 2019 Feb;37(2):237-240. doi: 10.1016/j.ajem.2018.05.036. Epub 2018 May 17.
- Background: PubMed 9322455Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
- Background: PubMed 12472704Kogan A, Katz J, Efrat R, Eidelman LA. Premedication with midazolam in young children: a comparison of four routes of administration. Paediatr Anaesth. 2002 Oct;12(8):685-9. doi: 10.1046/j.1460-9592.2002.00918.x.
- Background: PubMed 27129606Neville DN, Hayes KR, Ivan Y, McDowell ER, Pitetti RD. Double-blind Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department. Acad Emerg Med. 2016 Aug;23(8):910-7. doi: 10.1111/acem.12998.
- 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.
Brittany J DiFabio, MD principal investigator
University of Texas at Austin
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal Fentanyl Spray and Intranasal Midazolam Spray and Intranasal Midazolam Spray in people with Facial Laceration and Anxiety, run by University of Texas at Austin.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brittany J DiFabio, MD (512-324-0093, brittany.difabio@ascension.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Yale Preoperative Anxiety Score (mYPAS) (time frame: Pre-procedure). 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 NCT04745260, which also lists 7 linked publications.
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 9 Feb 2021.