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

This study has been completed.
Sponsor:
Collaborator:
University of Milano Bicocca
Information provided by:
San Gerardo Hospital
ClinicalTrials.gov Identifier:
NCT01096797
First received: March 29, 2010
Last updated: March 30, 2010
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Adenotonsillectomy
Postoperative Pain
Emergence Delirium
Drug: Sevoflurane
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Cohort Study Evaluating Incidence and Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children

Resource links provided by NLM:


Further study details as provided by San Gerardo Hospital:

Primary Outcome Measures:
  • Emergence delirium evaluation: Pediatric Anesthesia Emergence Delirium scale (PAED) [ Time Frame: First 15 minutes after awakening. ] [ Designated as safety issue: No ]
    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) [ Time Frame: 15 minutes after awakening ] [ Designated as safety issue: No ]
    • 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 [ Designated as safety issue: No ]
    Age groups: 2 to 4 ys and 5 to 6 ys

  • Time of exposure to sevoflurane [ Designated as safety issue: No ]
  • Awakening time [ Designated as safety issue: No ]
    Time between end of sevoflurane exposure and extubation


Enrollment: 150
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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

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

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096797

Locations
Italy
Department of Perioperative Medicine and Intensive Care. San Gerardo Hospital
Monza, MB, Italy, 20052
Sponsors and Collaborators
San Gerardo Hospital
University of Milano Bicocca
Investigators
Principal Investigator: Pablo M Ingelmo, MD Department of anesthesiology and resuscitation I, San Gerardo Hospital
  More Information

Publications:
Responsible Party: Pablo Mauricio Ingelmo, U.O. Anestesia e Rianimazione I. San Gerardo Hospital
ClinicalTrials.gov Identifier: NCT01096797     History of Changes
Other Study ID Numbers: AR-HSG 02-2009
Study First Received: March 29, 2010
Last Updated: March 30, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Pain, Postoperative
Delirium
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Sevoflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014