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Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children

NCT01096797 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-03-31

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Milano Bicocca

    collaborator OTHER

  • San Gerardo Hospital

    lead OTHER

Principal Investigators

  • Pablo M Ingelmo, MD · Department of anesthesiology and resuscitation I, San Gerardo Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096797 on ClinicalTrials.gov