Pediatric DeliriumPhase 4NCT04669457
Pediatric Delirium
A Phase 4 study testing Intra-nasal Dexmedetomidine and Oral Midazolam in people with Pediatric Delirium, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam. Read more about this study
- Who is it for?
- Ages 3 months to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Delirium
- What is being tested?
- Intra-nasal Dexmedetomidine and Oral Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 5 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 3 months to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects age 3 months to 9 years
- Scheduled to undergo a myringotomy
- American Society of Anesthesiologists (ASA) classification of I - II.
Who cannot join
- Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.
- Anyone age 10 years or older.
- Anyone with an ASA classification of III or higher.
- Non-English language speaker for whom short form consent is not available.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.
Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.
Read the detailed description
Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral/rectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.
- Conditions
- Pediatric Delirium
- Being tested
- Intra-nasal Dexmedetomidine, Oral Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-nasal DexmedetomidineDrug
Also called Precedex
Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.
Oral MidazolamDrug
Also called Midazolam
Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Intra-nasal Dexmedetomidine | Experimental | Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room. Receives: Drug: Intra-nasal Dexmedetomidine |
| Oral Midazolam | Active comparator | Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Receives: Drug: Oral Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of pediatric delirium
Time from when the patient is woken from anesthesia to the onset of delirium.
Measured: Zero minutes to 48 hours
Time to offset of pediatric delirium
Time from onset of delirium to the offset of delirium.
Measured: Zero minutes to 48 hours
Duration of pediatric delirium
Total time patient experiences delirium
Measured: Zero minutes to 48 hours
Secondary outcomes (7)
Drug Acceptance
The willingness of the subject to take the drug was assessed in the pre-operative area
Measured: 10-25 minutes prior to surgery
Parental Separation Anxiety Scale (PSAS)
Anxiety score was determined when the child was separated from the parents according to four levels.
Measured: 0-48 hours
Mask Acceptance Scale
The child's acceptance of the mask by the anesthesiologist was rated as follows.
Measured: 1-10 minutes prior to surgery
End tidal Sevoflurane value
During the surgery and at the time when patient leaves the OR End tidal Sevoflurane value will be documented.
Measured: 0-12 hours
Rescue analgesia in PACU
The amount and dose of oral/rectal acetaminophen given in PACU was recorded.
Measured: 0-6 hours post surgery
Home Behavior Analysis
The child's parents were given a diary to document their behavior for 48 hours post-operatively at home.
Measured: 12-48 hours
Oral analgesic use
Document intake of oral analgesics like acetaminophen or ibuprofen
Measured: Two days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start27 Apr 2021
- Primary completion5 Apr 2027 (estimated)
- Study completion5 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DeliriumStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Ian Richmond, University of Massachusetts, Worcester
- Investigators
- R. Ian Richmond, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669457
- Sponsor's protocol ID
- H00021788
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2020
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared via publication as group data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.
- ClinicalTrials.gov ID
- NCT04669457
- Acronym / sponsor ID
- H00021788
- Conditions
- Pediatric Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 16 Dec 2020 (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.
Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.
Detailed description
Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral/rectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Intra-nasal Dexmedetomidine | Experimental | Drug: Intra-nasal DexmedetomidineSubjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room. |
| Oral Midazolam | Active comparator | Drug: Oral MidazolamSubjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. |
Who may qualify
- Ages
- 3 months to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects age 3 months to 9 years
- Scheduled to undergo a myringotomy
- American Society of Anesthesiologists (ASA) classification of I - II.
Key exclusion criteria (4 listed)
- Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.
- Anyone age 10 years or older.
- Anyone with an ASA classification of III or higher.
- Non-English language speaker for whom short form consent is not available.
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 |
|---|---|---|
| Intra-nasal DexmedetomidineAlso: PrecedexSubjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room. | Drug | Intra-nasal Dexmedetomidine |
| Oral MidazolamAlso: MidazolamSubjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. | Drug | Oral Midazolam |
Primary outcome
Time to onset of pediatric delirium
Time frame: Zero minutes to 48 hours
Time from when the patient is woken from anesthesia to the onset of delirium.
Time to offset of pediatric delirium
Time frame: Zero minutes to 48 hours
Time from onset of delirium to the offset of delirium.
Duration of pediatric delirium
Time frame: Zero minutes to 48 hours
Total time patient experiences delirium
7 secondary outcomes
Drug Acceptance
Time frame: 10-25 minutes prior to surgery
Parental Separation Anxiety Scale (PSAS)
Time frame: 0-48 hours
Mask Acceptance Scale
Time frame: 1-10 minutes prior to surgery
End tidal Sevoflurane value
Time frame: 0-12 hours
Rescue analgesia in PACU
Time frame: 0-6 hours post surgery
Home Behavior Analysis
Time frame: 12-48 hours
Oral analgesic use
Time frame: Two days post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No. Data will be shared via publication as group data.
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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.
R. Ian Richmond, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intra-nasal Dexmedetomidine and Oral Midazolam in people with Pediatric Delirium, run by University of Massachusetts, Worcester at 1 site 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 15 Jul 2026. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Time to onset of pediatric delirium (time frame: Zero minutes to 48 hours). The study lists 3 primary outcomes in all. 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 15 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.