Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children

Postoperative Pain Clinical Trial

— e-PONB ENT  

Official title:

Prospective Cohort Study Evaluating Incidence and Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096797
• Other study ID #: AR-HSG 02-2009
• Status: Completed
• Phase: Phase 4
• First received: March 29, 2010
• Last updated: March 30, 2010
• Start date: November 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2009
• Source: San Gerardo Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenotonsillectomy
• Delirium
• Emergence Delirium
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	Department of Perioperative Medicine and Intensive Care. San Gerardo Hospital	Monza	MB

Sponsors (2)

Lead Sponsor	Collaborator
San Gerardo Hospital	University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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;10 — View Citation

Holzki J, Kretz FJ. Changing aspects of sevoflurane in paediatric anaesthesia: 1975-99. Paediatr Anaesth. 1999;9(4):283-6. — View Citation

Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. — View Citation

Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. — View 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):1625-30, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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	No
Secondary	Age	Age groups: 2 to 4 ys and 5 to 6 ys		No
Secondary	Time of exposure to sevoflurane			No
Secondary	Awakening time	Time between end of sevoflurane exposure and extubation		No