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

Phase 3

Completed

• Conditions: Is an Only Child
• Interventions: Drug: Clonidine

• Registration Number: NCT02181543
• Lead Sponsor: Professor Fernando Figueira Integral Medicine Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative agitation	6 hours	Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED).

Secondary Outcome Measures

Name	Time	Method
Duration of postoperative agitation	6 hours	Time in minutes.
Parental satisfaction.	24 hours	As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital.
Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters	6 hours	If any accident occurs in the recovery room, and postoperative (falls, bruises) disconnection of intravenous catheter or injuries.
Need for post-anesthetic drugs for treatment of agitation	6 hours	Use of any drugs, such as sedatives, opioids, anti-inflammatory or anti-emetic for improvement agitation.
Drowsiness	6 hours	Clinical evaluation: patient awake, awake, alert or patient under hypnosis.

Trial Locations

Locations (1)

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP); 🇧🇷 Recife, Pernambuco, Brazil