Pediatric Procedural SedationNCT07768566
Intranasal Dexmedetomidine vs. Oral Chloral Hydrate for Pediatric Orthopedic Procedural Sedation
A study testing Dexmedetomidine and Chloral Hydrate in people with Pediatric Procedural Sedation, run by Seoul National University Childrens Hospital at 1 site in South Korea.
Trial summary
This prospective randomized controlled study will compare the effectiveness and safety of intranasal dexmedetomidine with oral chloral hydrate for procedural sedation in children undergoing painful orthopedic manipulation. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Pediatric Procedural Sedation
- What is being tested?
- Dexmedetomidine and Chloral Hydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 7 through 12 years of age who require a painful orthopedic procedure in the pediatric orthopedic outpatient clinic or emergency department
- American Society of Anesthesiologists physical status class I or II
- The participant and parent or legal guardian understand the purpose of the study, the parent or legal guardian provides written informed consent, and the child provides assent
Who cannot join
- History of allergy to dexmedetomidine or chloral hydrate
- History of cardiovascular disease, including bradycardia or hypotension, or severe respiratory disease
- Current sedative use or receipt of another sedative within the previous 24 hours
- Inability to receive intranasal administration, including nasal obstruction or severe rhinitis
- Investigator determination that participation is inappropriate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 03080
Wonik Lee, +82-10-9212-0941, wonik@snu.ac.kr
About this study
Official title: Procedural Sedation With Intranasal Dexmedetomidine Versus Oral Chloral Hydrate for Painful Orthopedic Manipulation: A Prospective Randomized Controlled Study
This prospective randomized controlled study will compare the effectiveness and safety of intranasal dexmedetomidine with oral chloral hydrate for procedural sedation in children undergoing painful orthopedic manipulation. Forty-four children 7 to 12 years of age will be assigned in a 1:1 ratio to receive either intranasal dexmedetomidine 3 micrograms/kg plus oral saline or oral chloral hydrate 50 mg/kg plus intranasal saline. Both the participants and the clinicians performing the procedure will be blinded to treatment assignment. The primary outcome is successful sedation throughout the procedure, defined as a Pediatric Sedation State Scale (PSSS) score maintained between 1 and 4. Secondary outcomes include time to sedation, recovery time, sedation without movement, need for rescue sedation, vital-sign safety events, other adverse events, and participant, parent, and clinician satisfaction.
Read the detailed description
Children may have difficulty cooperating during painful orthopedic procedures because of pain, fear, and environmental stress. Oral chloral hydrate has been widely used for pediatric sedation but may cause vomiting, prolonged recovery, and respiratory depression. Dexmedetomidine is an alpha-2 adrenergic agonist with sedative and analgesic effects, minimal respiratory depression, and a noninvasive intranasal route of administration. Evidence comparing these drugs specifically during painful pediatric orthopedic manipulation is limited.
Eligible participants will be randomized in a double-blind, double-dummy design. The control group will receive oral chloral hydrate 50 mg/kg and intranasal saline. The experimental group will receive oral saline and intranasal dexmedetomidine 3 micrograms/kg delivered with a mucosal atomizer device. Both preparations will be administered 30 minutes before the planned procedure. Standard local anesthesia will be used in both groups according to the procedure, including a hematoma block for fracture reduction and lidocaine infiltration for pin removal.
Heart rate, respiratory rate, and oxygen saturation will be monitored before and after dosing and during sedation and recovery. PSSS will be assessed every 5 minutes from dosing through the end of the procedure. If sedation remains insufficient and the procedure cannot be performed 30 minutes after dosing, rescue sedation may be given at one-half of the initial dose using the same administration route. Participants will be observed until full recovery, which is expected to require approximately 3 to 4 hours from study-drug administration.
- Conditions
- Pediatric Procedural Sedation
- Being tested
- Dexmedetomidine, Chloral Hydrate, Intranasal Saline Placebo, Oral Saline Placebo
- Keywords
- Dexmedetomidine, Chloral Hydrate, Painful Orthopedic Manipulation, Pediatric Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine 3 micrograms/kg administered intranasally through a mucosal atomizer device 30 minutes before the planned procedure. The dose is divided between both nostrils.
Chloral HydrateDrug
Chloral hydrate 50 mg/kg administered orally 30 minutes before the planned procedure.
Intranasal Saline PlaceboDrug
An equal volume of normal saline administered intranasally 30 minutes before the planned procedure to maintain the double-dummy masking.
Oral Saline PlaceboDrug
An equal volume of normal saline administered orally 30 minutes before the planned procedure to maintain the double-dummy masking.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Dexmedetomidine Group | Experimental | Participants receive intranasal dexmedetomidine 3 micrograms/kg plus an equal-volume oral saline placebo 30 minutes before painful orthopedic manipulation. Receives: Drug: Dexmedetomidine; Drug: Oral Saline Placebo |
| Oral Chloral Hydrate Group | Active comparator | Participants receive oral chloral hydrate 50 mg/kg plus an equal-volume intranasal saline placebo 30 minutes before painful orthopedic manipulation. Receives: Drug: Chloral Hydrate; Drug: Intranasal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Sedation Success Based on the Pediatric Sedation State Scale
Number and percentage of participants with a PSSS score maintained from 1 through 4 throughout the procedure. The highest PSSS score observed from procedure start through procedure end represents the lowest level of sedation. PSSS ranges from 0 to 5; lower scores indicate deeper sedation. A score of 0 indicates a serious oversedation event requiring respiratory support, and a score of 5 indicates insufficient sedation that interferes with the procedure. Any score of 0 or 5 is classified as sedation failure.
Measured: From procedure start through procedure completion, assessed every 5 minutes within the approximately 3 to 4-hour study participation period
Secondary outcomes (9)
Time to Sedation
Elapsed time from the start of study-drug administration until the first PSSS score of 1, 2, 3, or 4.
Measured: From study-drug administration until sedation is reached, expected within 30 minutes after dosing
Recovery Time
Elapsed time from attainment of sedation (PSSS 1 to 3) until the PSSS returns to 4 or 5.
Measured: From attainment of sedation through recovery, within the approximately 3 to 4-hour study participation period
Sedation Success Without Movement
Number and percentage of participants with a PSSS score maintained from 1 through 3 throughout the procedure, indicating successful sedation without movement.
Measured: From procedure start through procedure completion, assessed every 5 minutes
Need for Rescue Sedation
Number and percentage of participants requiring rescue sedation because the procedure cannot be performed 30 minutes after dosing due to insufficient sedation. Rescue sedation uses one-half of the initial dose through the same administration route.
Measured: From 30 minutes after initial dosing through procedure completion
Vital-Sign Safety Events
Number and percentage of participants with any prespecified vital-sign safety event: heart rate decrease of at least 30% from baseline, apnea lasting at least 20 seconds, oxygen saturation below 95%, or a decrease in oxygen saturation of at least 10% from baseline lasting more than 10 seconds.
Measured: From study-drug administration through recovery, within the approximately 3 to 4-hour study participation period
Other Adverse Events
Number and percentage of participants with nausea or vomiting, allergic reaction, or other adverse events observed after study-drug administration.
Measured: From study-drug administration through recovery, within the approximately 3 to 4-hour study participation period
Participant Satisfaction
Participant-rated satisfaction with treatment on a 4-point Likert scale: 1=excellent, 2=good, 3=fair, and 4=poor. Lower scores indicate greater satisfaction.
Measured: After procedure completion and before discharge, within the approximately 3 to 4-hour study participation period
Parent Satisfaction
Parent-rated satisfaction with treatment on a 4-point Likert scale: 1=excellent, 2=good, 3=fair, and 4=poor. Lower scores indicate greater satisfaction.
Measured: After procedure completion and before discharge, within the approximately 3 to 4-hour study participation period
Proceduralist Satisfaction
Proceduralist-rated satisfaction with treatment on a 4-point Likert scale: 1=excellent, 2=good, 3=fair, and 4=poor. Lower scores indicate greater satisfaction.
Measured: After procedure completion, within the approximately 3 to 4-hour study participation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Procedural SedationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, randomized, double-blind, double-dummy comparison.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Childrens Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital
- Responsible party
- Principal investigator, Mi Hyun Song, Seoul National University Hospital
- Investigators
- Mi Hyun Song, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768566
- Sponsor's protocol ID
- H-2504-032-1629
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing plan has been established.