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

Primary Purpose

Is an Only Child

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Clonidine

About this trial

This is an interventional prevention trial for Is an Only Child focused on measuring Clonidine, Psychomotor agitation, Anesthesia recovery period, Tonsillectomy, Child, preschool

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Clonidine

No Clonidine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative agitation

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

Secondary Outcome Measures

Duration of postoperative agitation

Time in minutes.

Need for post-anesthetic drugs for treatment of agitation

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

If any accident occurs in the recovery room, and postoperative (falls, bruises) disconnection of intravenous catheter or injuries.

Drowsiness

Clinical evaluation: patient awake, awake, alert or patient under hypnosis.

Parental satisfaction.

As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital.

Full Information

NCT ID

NCT02181543

First Posted

July 2, 2014

Last Updated

October 3, 2017

Sponsor

Professor Fernando Figueira Integral Medicine Institute

1. Study Identification

Unique Protocol Identification Number

NCT02181543

Brief Title

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

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

August 2013 (Actual)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Professor Fernando Figueira Integral Medicine Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Is an Only Child

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clonidine

Arm Type

Experimental

Arm Description

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

Arm Title

No Clonidine

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Clonidine

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative agitation

Description

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

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Duration of postoperative agitation

Description

Time in minutes.

Time Frame

6 hours

Title

Need for post-anesthetic drugs for treatment of agitation

Description

Use of any drugs, such as sedatives, opioids, anti-inflammatory or anti-emetic for improvement agitation.

Time Frame

6 hours

Title

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

Description

If any accident occurs in the recovery room, and postoperative (falls, bruises) disconnection of intravenous catheter or injuries.

Time Frame

6 hours

Title

Drowsiness

Description

Clinical evaluation: patient awake, awake, alert or patient under hypnosis.

Time Frame

6 hours

Title

Parental satisfaction.

Description

As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alex SR Souza, PhD

Organizational Affiliation

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fernando A Souza Júnior, MD

Organizational Affiliation

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tania CM Couceiro, MD

Organizational Affiliation

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ítalo GM Santos, Student

Organizational Affiliation

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Luciana C Lima, PhD

Organizational Affiliation

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Official's Role

Study Director

Facility Information:

Facility Name

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

City

Recife

State/Province

Pernambuco

ZIP/Postal Code

50.070-550

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

19326585

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.

Results Reference

background

PubMed Identifier

18372935

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.

Results Reference

background

PubMed Identifier

11473855

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.

Results Reference

result

PubMed Identifier

16677266

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.

Results Reference

result

PubMed Identifier

11133600

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.

Results Reference

result

PubMed Identifier

17416907

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.

Results Reference

result

PubMed Identifier

33712253

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.

Results Reference

derived

Links:

URL

http://www.imip.org.br

Description

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

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

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