CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
Sevofluranedrug
Likely dose
Sevoflurane 6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01096797
NCT01096797Phase 4Completed
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Prospective Cohort Study Evaluating Incidence and Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children

San Gerardo Hospital·interventional·Posted Mar 31, 2010·Updated Mar 31, 2010

In Brief

A Phase 4 clinical trial evaluating Sevoflurane for Adenotonsillectomy and 2 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenotonsillectomy, Postoperative Pain, Emergence Delirium
CountriesItaly
CollaboratorsUniversity of Milano Bicocca

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 31, 2010
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.3 years ago

Interventions

Sevofluranedrug

* 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