Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children
NCT ID: NCT01096797
Last Updated: 2010-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2009-11-30
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Children undergoing adenotonsillectomy
Children between 2-6 years old undergoing elective adenoidectomy with or without tonsillectomy from the ENT Service of the San Gerardo Hospital.
Sevoflurane
* 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
Interventions
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Sevoflurane
* 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
6 Years
ALL
No
Sponsors
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University of Milano Bicocca
OTHER
San Gerardo Hospital
OTHER
Responsible Party
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U.O. Anestesia e Rianimazione I. San Gerardo Hospital
Principal Investigators
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Pablo M Ingelmo, MD
Role: PRINCIPAL_INVESTIGATOR
Department of anesthesiology and resuscitation I, San Gerardo Hospital
Locations
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Department of Perioperative Medicine and Intensive Care. San Gerardo Hospital
Monza, MB, Italy
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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AR-HSG 02-2009
Identifier Type: -
Identifier Source: org_study_id