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Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children (e-PONB ENT)

Primary Purpose

Adenotonsillectomy, Postoperative Pain, Emergence Delirium

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Sevoflurane
Sponsored by
San Gerardo Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenotonsillectomy

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and Female children from 2 to 6 years of age
  • American Society of Anaesthesiologists Classification (ASA) I: without systemic disease
  • American Society of Anaesthesiologists Classification (ASA) II: moderate systemic disease
  • Scheduled for elective tonsillectomy and/or adenoidectomy.
  • Children whose parents (or legal tutors) have given their informed written consent

Exclusion Criteria:

  • Emergency surgery.
  • Children whose parents (or legal tutors) denied their own consensus
  • Children with known cognitive impairment
  • A story of kidney, liver, pulmonary or cardiac disease.
  • A history of chronic pain or use of analgesic drugs.
  • Familiar or personal history of malignant hyperthermia
  • Need premedication or total intravenous anaesthesia.

Sites / Locations

  • Department of Perioperative Medicine and Intensive Care. San Gerardo Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children undergoing adenotonsillectomy

Arm Description

Children between 2-6 years old undergoing elective adenoidectomy with or without tonsillectomy from the ENT Service of the San Gerardo Hospital.

Outcomes

Primary Outcome Measures

Emergence delirium evaluation: Pediatric Anesthesia Emergence Delirium scale (PAED)
Pediatric Anesthesia Emergence Delirium scale(PAED):The PAED scale consists of five psychometric items. To each of them it's possible to assign a score from 0 to 4 (maximum score 20 points). Emergence delirium was defined as a PAED scale score of 10 points of grater.
Pain: Face, Legs, Activity, Cry, Consolability Scale (FLACCS); Children and Infants Postoperative Pain Scale (CHIPPS); Children Hospital of Eastern Ontario Pain Scale (CHEOPS)
FLACCS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater. CHIPPS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater. CHEOPS: five behavioural items scale with a maximum score of 13 points. Significant pain behaviour correspond to a CHEOPS score of 7 points or greater

Secondary Outcome Measures

Age
Age groups: 2 to 4 ys and 5 to 6 ys
Time of exposure to sevoflurane
Awakening time
Time between end of sevoflurane exposure and extubation

Full Information

First Posted
March 29, 2010
Last Updated
March 30, 2010
Sponsor
San Gerardo Hospital
Collaborators
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT01096797
Brief Title
Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children
Acronym
e-PONB ENT
Official Title
Prospective Cohort Study Evaluating Incidence and Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
San Gerardo Hospital
Collaborators
University of Milano Bicocca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the incidence of pain, emergence delirium and the combination of those postoperative negative behaviours during the first 15 minutes after awakening from sevoflurane anesthesia in pre-school children. Additionally this study will evaluate the relationship between emergence delirium and postoperative pain behaviour after adenotonsil surgery.
Detailed Description
Tonsillectomy and/or adenoidectomy is the most common surgery performed in paediatric population. Sevoflurane is the most frequently volatile anaesthetic used in paediatric population. It is well tolerated, allows rapid anaesthesia induction, faster emergence, orientation. A child who emerges from sevoflurane anaesthesia may experience a variety of behavioural disturbances described as "emergence delirium" (ED). ED has been described as "a mental disturbance during the recovery from general anaesthesia consisting of hallucinations, delusions and confusion manifested by moaning, restlessness, involuntary physical activity, and thrashing about in bed" in the immediate post anaesthesia period. Additionally paranoid ideation has been observed in combination with these emergence behaviours. Restless recovery from anaesthesia is an important problem. It may lead, along with injury to the child, bleeding from surgical site, to accidental removal of IV catheters and drains. Once ED occur, extra nursing care may be necessary, as well as supplemental sedative and/or analgesic medications, which may be associated to respiratory depression or airway obstruction and may delay patient discharge. Although long-term psychological implications of ED remain unknown, children with restless recovery from anaesthesia are seven times more likely to have new-onset separation anxiety, apathy, eating and sleep problems. ED after sevoflurane anaesthesia has been suggested both to be and not to be associated with postoperative pain behaviour. Accordingly, adequate pain relief has been found to reduce or have no effect on ED after sevoflurane anaesthesia. Because a self-evaluation is difficult In preschool boy observational scales based on behaviour like CHIPPS, FLACC or CHEOPS are used for the measurement of pain. Given that the child's behaviour evaluation at emergence is made with observational scales, a superimposition between ED and pain measurement is possible. Nurses and doctors using behavioural scales for the evaluation of ED and pain may not be able to differentiate pain from ED during awakening. This may led to the treatment of an autolimitated disturb (ED) or to the under treatment of pain after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenotonsillectomy, Postoperative Pain, Emergence Delirium

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children undergoing adenotonsillectomy
Arm Type
Experimental
Arm Description
Children between 2-6 years old undergoing elective adenoidectomy with or without tonsillectomy from the ENT Service of the San Gerardo Hospital.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Anaesthesia induction: sevoflurane 4 to 6% by mask and IV propofol 2-6 mg/kg. Anaesthesia maintenance: sevoflurane 2-3 % Intraoperative and postoperative analgesia: IV fentanyl 1,5-2,5 mcg/kg, IV paracetamol 15 mg/kg Prevention of postoperative nausea and vomiting: dexamethasone 0,1 mg/kg, ondansetron 0,1 mg/kg
Primary Outcome Measure Information:
Title
Emergence delirium evaluation: Pediatric Anesthesia Emergence Delirium scale (PAED)
Description
Pediatric Anesthesia Emergence Delirium scale(PAED):The PAED scale consists of five psychometric items. To each of them it's possible to assign a score from 0 to 4 (maximum score 20 points). Emergence delirium was defined as a PAED scale score of 10 points of grater.
Time Frame
First 15 minutes after awakening.
Title
Pain: Face, Legs, Activity, Cry, Consolability Scale (FLACCS); Children and Infants Postoperative Pain Scale (CHIPPS); Children Hospital of Eastern Ontario Pain Scale (CHEOPS)
Description
FLACCS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater. CHIPPS: five behavioural items scale with a maximum score of 10 points. Significant pain behaviour correspond to a FLACCS score of 4 points or greater. CHEOPS: five behavioural items scale with a maximum score of 13 points. Significant pain behaviour correspond to a CHEOPS score of 7 points or greater
Time Frame
15 minutes after awakening
Secondary Outcome Measure Information:
Title
Age
Description
Age groups: 2 to 4 ys and 5 to 6 ys
Title
Time of exposure to sevoflurane
Title
Awakening time
Description
Time between end of sevoflurane exposure and extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female children from 2 to 6 years of age American Society of Anaesthesiologists Classification (ASA) I: without systemic disease American Society of Anaesthesiologists Classification (ASA) II: moderate systemic disease Scheduled for elective tonsillectomy and/or adenoidectomy. Children whose parents (or legal tutors) have given their informed written consent Exclusion Criteria: Emergency surgery. Children whose parents (or legal tutors) denied their own consensus Children with known cognitive impairment A story of kidney, liver, pulmonary or cardiac disease. A history of chronic pain or use of analgesic drugs. Familiar or personal history of malignant hyperthermia Need premedication or total intravenous anaesthesia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo M Ingelmo, MD
Organizational Affiliation
Department of anesthesiology and resuscitation I, San Gerardo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Perioperative Medicine and Intensive Care. San Gerardo Hospital
City
Monza
State/Province
MB
ZIP/Postal Code
20052
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
10411761
Citation
Holzki J, Kretz FJ. Changing aspects of sevoflurane in paediatric anaesthesia: 1975-99. Paediatr Anaesth. 1999;9(4):283-6. doi: 10.1046/j.1460-9592.1999.00415.x. No abstract available.
Results Reference
background
PubMed Identifier
15114210
Citation
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
Results Reference
result
PubMed Identifier
17179249
Citation
Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. doi: 10.1213/01.ane.0000250914.91881.a8.
Results Reference
result
PubMed Identifier
12760985
Citation
Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.
Results Reference
result
PubMed Identifier
20047899
Citation
Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, Nivoche Y, Constant I, Murat I. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010 Feb;104(2):216-23. doi: 10.1093/bja/aep376. Epub 2010 Jan 3.
Results Reference
result

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Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children

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