CompletedNot Applicable

Comparison Between Intranasal vs Intravenous Dexmedetomidine for EEG Sedation of Children With Behavior Disorders.

Italy48 participantsStarted 2018-03-01

Plain-language summary

The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders. Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive pediatric patients affected by behavioural disorders, who needed sedation for EEG recording. A group of children received IV administration of DEX, the following year a second group of children received IN administration of the same drug. Target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS).

Who can participate

Age range1 Month – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * children affected by behavioural disorders, who need sedation to perform EEG * American Society of Anaesthesiologists (ASA) status \< 3 * Written informed consent by a parent or legal guardian. Exclusion Criteria: * previous hypersensitivity reaction or contraindications to administration of DEX (cardiac failure, cardiac arrhythmias, long QT syndrome, bradycardia, hypotension, use of beta-blockers or digoxin, uncontrolled arterial hypertension, recent stroke or intracranial bleeding, Moya-Moya syndrome) * for IN administration, children with runny nose/mild respiratory infection

What they're measuring

efficacy (PSSS level 2)

Timeframe: 20 minutes after dexmedetomidine administration

Trial details

NCT IDNCT06434428

SponsorAzienda Ospedaliera di Padova

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-08-30

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