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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chloral hydrate group | Active Comparator | chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline) |
|
| low dose dexmedetomidine Group | Experimental | Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position. |
|
| high dose dexmedetomidine group | Experimental | Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chloral hydrate Group | Drug | chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline) |
|
| Measure | Description | Time Frame |
|---|---|---|
| successful rescue sedation rate | 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 | up to 1 hours after MRI scaning |
| Measure | Description | Time Frame |
|---|---|---|
| sedation induction time | 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
|
| Measure | Description | Time Frame |
|---|---|---|
| non-invasive systolic blood pressure | changes in the non-invasive systolic blood pressure at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration | baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration |
| heart rate |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology of Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong | 510000 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34397100 | Derived | Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3. | |
| 26714442 | Derived | Zhang W, Wang Z, Song X, Fan Y, Tian H, Li B. Comparison of rescue techniques for failed chloral hydrate sedation for magnetic resonance imaging scans--additional chloral hydrate vs intranasal dexmedetomidine. Paediatr Anaesth. 2016 Mar;26(3):273-9. doi: 10.1111/pan.12824. Epub 2015 Dec 30. |
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| low dose dexmedetomidine group | Drug | Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup |
|
|
| high dose dexmedetomidine group | Drug | Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup |
|
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| up to 30 min after rescue drug administration |
| Wake -up time | 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 | up to 4 hours after rescue drug administration |
changes in heart rates at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration |
| baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration |
| Oxyhemoglobin desaturation | Significant Oxyhemoglobin desaturation was defined as<94% | baseline and four hours after rescue medicine administration |
| Guangzhou Women and Children's Medical Center |
| Guangzhou |
| Guangdong |
| China |
| 26616644 | Derived | Miller J, Xue B, Hossain M, Zhang MZ, Loepke A, Kurth D. Comparison of dexmedetomidine and chloral hydrate sedation for transthoracic echocardiography in infants and toddlers: a randomized clinical trial. Paediatr Anaesth. 2016 Mar;26(3):266-72. doi: 10.1111/pan.12819. Epub 2015 Nov 30. |