Administration Related Reaction, Chloral Hydrate Adverse Reaction, Failed Moderate Sedation During Procedure
Conditions
Brief summary
The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.
Interventions
DRUGchloral hydrate Group
chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
DRUGlow dose dexmedetomidine group
Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup
DRUGhigh dose dexmedetomidine group
Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
Sponsors
Guangzhou Women and Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 6 Months
Healthy volunteers
No
Inclusion criteria
* 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning
Exclusion criteria
* known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| successful rescue sedation rate | up to 1 hours after MRI scaning | Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Observer Assessment of Alertness and Sedation Scale (MOAA/S; Table 1). successful sedation was defined as an MOAA/S of between 0 and 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sedation induction time | up to 30 min after rescue drug administration | Successful sedation was defined as an MOAA/S of between 0 and 2, and sedation induction time was defined as the time from rescue drug administration to the onset of satisfactory sedation 0 Does not respond to a noxious stimulus 1. Does not respond to mild prodding or shaking 2. Responds only after mild prodding or shaking 3. Responds only after name is called loudly orrepeatedly 4. Lethargic response to name spoken in normal tone 5. Appears asleep, but responds readily to namespoken in normal tone 6. Appears alert and awake, responds readily to namespoken in normal tone |
| Wake -up time | up to 4 hours after rescue drug administration | Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke |
Other
| Measure | Time frame | Description |
|---|---|---|
| non-invasive systolic blood pressure | baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration | changes in the non-invasive systolic blood pressure at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration |
| heart rate | baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration | changes in heart rates at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration |
| Oxyhemoglobin desaturation | baseline and four hours after rescue medicine administration | Significant Oxyhemoglobin desaturation was defined as\<94% |
Countries
China
Outcome results
None listed