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

Information source: Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Is an Only Child

Intervention: Clonidine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Professor Fernando Figueira Integral Medicine Institute

Official(s) and/or principal investigator(s):
Alex SR Souza, PhD, Principal Investigator, Affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Fernando A Souza Júnior, MD, Study Chair, Affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Tania CM Couceiro, MD, Study Chair, Affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Ítalo GM Santos, Student, Study Chair, Affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Luciana C Lima, PhD, Study Director, Affiliation: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Primary outcome: Postoperative agitation

Secondary outcome:

Duration of postoperative agitation

Need for post-anesthetic drugs for treatment of agitation

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

Drowsiness

Parental satisfaction.

Eligibility

Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.

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.

Locations and Contacts

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco 50.070-550, Brazil
Additional Information

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Related publications:

Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. Review.

Silva LM, Braz LG, Módolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: doi:10.2223/JPED.1763. Review.

Starting date: August 2013
Last updated: December 8, 2014

Page last updated: August 20, 2015

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