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To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.
Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth.
The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized dexmedetomidine and ketamine | Experimental | Pre-operative nebulization of dexmedetomidine and ketamine |
|
| Nebulized dexmedetomidine | Active Comparator | Pre-operative nebulization of dexmedetomidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulization of dexmedetomidine and ketamine | Drug | Pre-operative nebulization of dexmedetomidine and ketamine |
|
| Measure | Description | Time Frame |
|---|---|---|
| University of Michigan Sedation Scale (UMSS) | It ranges from 0 = awake, alert to 4 = unarousable | Pre-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Separation using the Parenteral Separation Anxiety Scale (PSAS) | It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome. | Pre-operative |
| Watcha scale for emergence delirium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma N. Mohamed, M.D. | Contact | +201003633992 | fatmanabil2012@aun.edu.eg | |
| Samar Ah. Abdellah, M.B.B.Ch. | Contact | +201095769703 | samarahmed1810@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Recruiting | Asyut | 71515 | Egypt |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Nebulization of dexmedetomidine | Drug | Pre-operative nebulization of dexmedetomidine |
|
It ranges from 1= calm to 4 = agitated
| Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |