Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children

NCT01096797 | Completed Phase 4

• 1 other identifier: AR-HSG 02-2009
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenotonsillectomy; Postoperative Pain; Emergence Delirium

Outcome Measures

Primary Outcomes (2)

• 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.

  First 15 minutes after awakening.

• 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

  15 minutes after awakening

Secondary Outcomes (3)

• Age

• Time of exposure to sevoflurane

• Awakening time

Study Arms (1)

Children undergoing adenotonsillectomy

EXPERIMENTAL

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

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

* 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

Children undergoing adenotonsillectomy

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Gerardo Hospital: lead
• University of Milano Bicocca: collaborator

Study Sites (1)

Department of Perioperative Medicine and Intensive Care. San Gerardo Hospital

Monza, MB, 20052, Italy

Location

Related Publications (5)

• 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.

  PMID: 10411761 BACKGROUND

• 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.

  PMID: 15114210 RESULT

• 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.

  PMID: 17179249 RESULT

• 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.

  PMID: 12760985 RESULT

• 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.

  PMID: 20047899 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Emergence Delirium

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Pablo M Ingelmo, MD

  Department of anesthesiology and resuscitation I, San Gerardo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 31, 2010
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 31, 2010

Record last verified: 2009-11

Locations

IT (1)