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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02181543

Enrollment

Registered

2014-07-04

Start date

2013-08-31

Completion date

2014-12-31

Last updated

2017-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Is an Only Child

Keywords

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

Brief summary

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

Interventions

DRUGClonidine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative agitation	6 hours	Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED).

Secondary

Measure	Time frame	Description
Duration of postoperative agitation	6 hours	Time in minutes.
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.
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.
Drowsiness	6 hours	Clinical evaluation: patient awake, awake, alert or patient under hypnosis.
Parental satisfaction.	24 hours	As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026