Clinical trial NCT01096797: Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children
Official title: Prospective Cohort Study Evaluating Incidence and Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adenotonsillectomy
Postoperative Pain
Emergence Delirium
Lead sponsor: San Gerardo Hospital
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
First posted: 2010-03-31
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Emergence delirium evaluation: Pediatric Anesthesia Emergence Delirium scale (PAED)
timeFrame: First 15 minutes after awakening.
measure: Pain: Face, Legs, Activity, Cry, Consolability Scale (FLACCS); Children and Infants Postoperative Pain Scale (CHIPPS); Children Hospital of Eastern Ontario Pain Scale (CHEOPS)
timeFrame: 15 minutes after awakening
Secondary outcomes:
measure: Age
measure: Time of exposure to sevoflurane
measure: Awakening time
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Department of Perioperative Medicine and Intensive Care. San Gerardo Hospital
state: MB
Study officials:
affiliation: Department of anesthesiology and resuscitation I, San Gerardo Hospital
name: Pablo M Ingelmo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.