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The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine | Experimental | Clonidine 1μg/Kg, IV, single dose, anesthesia intraoperative. |
|
| No Clonidine | No Intervention | Usual care of Instituto de Medicina Integral Prof. Fernando Figueira. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | 1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative agitation | Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED). | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of postoperative agitation | Time in minutes. | 6 hours |
| Need for post-anesthetic drugs for treatment of agitation | Use of any drugs, such as sedatives, opioids, anti-inflammatory or anti-emetic for improvement agitation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex SR Souza, PhD | Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) | Principal Investigator |
| Fernando A Souza Júnior, MD | Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) | Study Chair |
| Tania CM Couceiro, MD | Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) | Study Chair |
| Ítalo GM Santos, Student | Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) | Study Chair |
| Luciana C Lima, PhD | Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) | Recife | Pernambuco | 50.070-550 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19326585 | Background | Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. doi: 10.1016/j.aorn.2008.12.026. | |
| 18372935 | Background | Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763. |
| Label | URL |
|---|---|
| Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) | View source |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 6 hours |
| Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters | If any accident occurs in the recovery room, and postoperative (falls, bruises) disconnection of intravenous catheter or injuries. | 6 hours |
| Drowsiness | Clinical evaluation: patient awake, awake, alert or patient under hypnosis. | 6 hours |
| Parental satisfaction. | As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital. | 24 hours |
| 11473855 | Result | Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page. |
| 16677266 | Result | Malviya S, Voepel-Lewis T, Ramamurthi RJ, Burke C, Tait AR. Clonidine for the prevention of emergence agitation in young children: efficacy and recovery profile. Paediatr Anaesth. 2006 May;16(5):554-9. doi: 10.1111/j.1460-9592.2006.01818.x. |
| 11133600 | Result | Fazi L, Jantzen EC, Rose JB, Kurth CD, Watcha MF. A comparison of oral clonidine and oral midazolam as preanesthetic medications in the pediatric tonsillectomy patient. Anesth Analg. 2001 Jan;92(1):56-61. doi: 10.1097/00000539-200101000-00011. |
| 17416907 | Result | Tazeroualti N, De Groote F, De Hert S, De Ville A, Dierick A, Van der Linden P. Oral clonidine vs midazolam in the prevention of sevoflurane-induced agitation in children. a prospective, randomized, controlled trial. Br J Anaesth. 2007 May;98(5):667-71. doi: 10.1093/bja/aem071. Epub 2007 Apr 7. |
| 33712253 | Derived | Sousa-Junior FA, Souza ASR, Lima LC, Santos IGM, Menezes LAP, Ratis PAPL, Couceiro TCM. Intraoperative clonidine to prevent postoperative emergence delirium following sevoflurane anesthesia in pediatric patients: a randomized clinical trial. Braz J Anesthesiol. 2021 Jan-Feb;71(1):5-10. doi: 10.1016/j.bjane.2020.12.003. Epub 2020 Dec 25. |
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006571 |
| Heterocyclic Compounds |