Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, China | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2 ug/kg of intranasal dexmedetomidine could produce satisfactory sedation in more children for ophthalmic examinations than the sedative effect of 1ug/kg.
Dexmedetomidine is an a2-adrenergic receptor agonist that provides sedation without respiratory depression.Clinical trials have demonstrated that intranasal dexmedetomidine in a dose of 1ug/kg produces satisfactory sedation in between 53% and 57% of children at anaesthetic induction. There are also reports using higher doses of intranasal dexmedetomidine. The investigators compared the sedative effect of 1ug/kg intranasal dexmedetomidine with those of 2 ug/kg for ophthalmic examinations in children aged 2 months-10 years and hypothesised that the higher dose would produce satisfactory sedation in more children at the time of anaesthetic induction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine 1 ug/kg | Active Comparator | 1 ug/kg of intranasal dexmedetomidine |
|
| Dexmedetomidine 2 ug/kg | Active Comparator | 2 ug/kg of intranasal dexmedetomidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal dexmedetomidine | Drug | 1 or 2 ug/kg of intranasal dexmedetomidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of participants with successful rescue sedation | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of participants with completement of ophthalmic examinations | 1 day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haotian Lin | Contact | 862087330493 | gddlht@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Haotian Lin, Ph.D. | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Xiaoliang Gan, Ph.D. | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23325950 | Background | Ambi US, Joshi C, Ganeshnavar A, Adarsh E. Intranasal dexmedetomidine for paediatric sedation for diagnostic magnetic resonance imaging studies. Indian J Anaesth. 2012 Nov;56(6):587-8. doi: 10.4103/0019-5049.104588. No abstract available. | |
| 18761245 | Background | Ray T, Tobias JD. Dexmedetomidine for sedation during electroencephalographic analysis in children with autism, pervasive developmental disorders, and seizure disorders. J Clin Anesth. 2008 Aug;20(5):364-368. doi: 10.1016/j.jclinane.2008.03.004. |
| Label | URL |
|---|---|
| Homepage of Zhongshan Ophthalmic Center | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Weirong Chen | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Director |
| Yizhi Liu, Ph.D. | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Chair |
| 24447296 | Result | Li BL, Yuen VM, Song XR, Ye J, Ni J, Huang JX, Irwin MG. Intranasal dexmedetomidine following failed chloral hydrate sedation in children. Anaesthesia. 2014 Mar;69(3):240-4. doi: 10.1111/anae.12533. Epub 2014 Jan 21. |
| 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. |
| 27229908 | Derived | Gan X, Lin H, Chen J, Lin Z, Lin Y, Chen W. Rescue Sedation With Intranasal Dexmedetomidine for Pediatric Ophthalmic Examination After Chloral Hydrate Failure: A Randomized, Controlled Trial. Clin Ther. 2016 Jun;38(6):1522-1529. doi: 10.1016/j.clinthera.2016.04.036. Epub 2016 May 24. |