Pediatric Procedural Sedation
Conditions
Keywords
Dexmedetomidine, Chloral Hydrate, Painful Orthopedic Manipulation, Pediatric Sedation
Brief 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. 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.
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine 3 micrograms/kg administered intranasally through a mucosal atomizer device 30 minutes before the planned procedure. The dose is divided between both nostrils.
DRUGChloral Hydrate
Chloral hydrate 50 mg/kg administered orally 30 minutes before the planned procedure.
An equal volume of normal saline administered intranasally 30 minutes before the planned procedure to maintain the double-dummy masking.
DRUGOral Saline Placebo
An equal volume of normal saline administered orally 30 minutes before the planned procedure to maintain the double-dummy masking.
Sponsors
Seoul National University Childrens Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, parents, treating clinicians, investigators, and outcome assessors are blinded. A research-independent third party generates the randomization list, and the clinical trials pharmacy prepares identically appearing oral and intranasal study products. Assignment information is released after database lock, except when emergency unblinding is required for participant safety.
Intervention model description
Two-arm, parallel-group, randomized, double-blind, double-dummy comparison.
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Sedation Success Based on the Pediatric Sedation State Scale | From procedure start through procedure completion, assessed every 5 minutes within the approximately 3 to 4-hour study participation period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Sedation | From study-drug administration until sedation is reached, expected within 30 minutes after dosing | Elapsed time from the start of study-drug administration until the first PSSS score of 1, 2, 3, or 4. |
| Recovery Time | From attainment of sedation through recovery, within the approximately 3 to 4-hour study participation period | Elapsed time from attainment of sedation (PSSS 1 to 3) until the PSSS returns to 4 or 5. |
| Sedation Success Without Movement | From procedure start through procedure completion, assessed every 5 minutes | Number and percentage of participants with a PSSS score maintained from 1 through 3 throughout the procedure, indicating successful sedation without movement. |
| Need for Rescue Sedation | From 30 minutes after initial dosing through procedure completion | 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. |
| Vital-Sign Safety Events | From study-drug administration through recovery, within the approximately 3 to 4-hour study participation period | 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. |
| Other Adverse Events | From study-drug administration through recovery, within the approximately 3 to 4-hour study participation period | Number and percentage of participants with nausea or vomiting, allergic reaction, or other adverse events observed after study-drug administration. |
| Participant Satisfaction | After procedure completion and before discharge, within the approximately 3 to 4-hour study participation period | 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. |
| Parent Satisfaction | After procedure completion and before discharge, within the approximately 3 to 4-hour study participation period | 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. |
| Proceduralist Satisfaction | After procedure completion, within the approximately 3 to 4-hour study participation period | 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. |
Countries
South Korea
Contacts
CONTACTWonik Lee
PRINCIPAL_INVESTIGATORMi Hyun Song
Seoul National University Hospital
Outcome results
None listed