Clinical trial NCT02181543: Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
Official title: Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Is an Only Child
Keywords: Clonidine
Psychomotor agitation
Anesthesia recovery period
Tonsillectomy
Child, preschool
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
First posted: 2014-07-04
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.


Eligibility criteria: Inclusion Criteria:

* Aged 2 - 12 Years.
* Need for tonsillectomy / adenotonsillectomy.
* Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or 3.
* Anestesia geral com sevoflurano.
* Use of Intraoperative dipyrone, 30-50mg/Kg, IV.

Exclusion Criteria:

* Changes in consciousness.
* Neurological Deficit.
* Use of another drug as medication before anesthesia.

Primary outcomes:
measure: Postoperative agitation
timeFrame: 6 hours
Secondary outcomes:
measure: Duration of postoperative agitation
timeFrame: 6 hours
measure: Need for post-anesthetic drugs for treatment of agitation
timeFrame: 6 hours
measure: Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters
timeFrame: 6 hours
measure: Drowsiness
timeFrame: 6 hours
measure: Parental satisfaction.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
state: Pernambuco
Study officials:
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
name: Alex SR Souza, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
name: Fernando A Souza Júnior, MD
role: STUDY_CHAIR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
name: Tania CM Couceiro, MD
role: STUDY_CHAIR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
name: Ítalo GM Santos, Student
role: STUDY_CHAIR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
name: Luciana C Lima, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page.
citation: 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.
citation: 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.
citation: 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.
citation: 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.