Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.

NCT02181543 | Completed Phase 3

• 1 other identifier: U1111-1157-8852
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Is an Only Child

Keywords

Clonidine; Psychomotor agitation; Anesthesia recovery period; Tonsillectomy; Child, preschool

Outcome Measures

Primary Outcomes (1)

• Postoperative agitation

  Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED).

  6 hours

Secondary Outcomes (5)

• Duration of postoperative agitation

  6 hours

• Need for post-anesthetic drugs for treatment of agitation

  6 hours

• Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters

  6 hours

• Drowsiness

  6 hours

• Parental satisfaction.

  24 hours

Study Arms (2)

Clonidine

EXPERIMENTAL

Clonidine 1μg/Kg, IV, single dose, anesthesia intraoperative.

Drug: Clonidine

No Clonidine

NO INTERVENTION

Usual care of Instituto de Medicina Integral Prof. Fernando Figueira.

Interventions

Clonidine DRUG

1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.

Clonidine

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

Study Sites (1)

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Recife, Pernambuco, 50.070-550, Brazil

Location

Related Publications (7)

• 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.

  PMID: 19326585 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.

  PMID: 18372935 BACKGROUND

• Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page.

  PMID: 11473855 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.

  PMID: 16677266 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.

  PMID: 11133600 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.

  PMID: 17416907 RESULT

• 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.

  PMID: 33712253 DERIVED

Related Links

• Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

BR (1)