Sleep Inducing for EEG Recording in Children: A Comparison between Triclofos, Melatonin, Promethazine and Hydroxyzine for sedation during EEG in Childre

Not Applicable

Conditions: Health Condition 1: G968- Other specified disorders of central nervous system

Registration Number: CTRI/2019/04/018713

Lead Sponsor: eeha Singh principal investigator

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Children aged 1-10 years, referred to EEG Unit of our hospital by a pediatric neurologist based on standard indications after a clinical assessment which was indicative of seizure or unclear spells or seizure-like events

2.Natural sleep could not be induced

3.Patient classified as American Society of Anesthesiology (ASA) class 1 (a normally healthy patient) or 2 (a patient with mild systemic disease: mild asthma, controlled diabetes mellitus)18.

Exclusion Criteria

1.Presence of gastritis or any other serious systemic diseases

2.Any previous allergic reaction to any agent

3.Received a sedative or hypnotic agent within the past 48 hours

4.Severe tonsillar or adenoid hypertrophy

5.Being treated with medications that have critical interactions with these sedatives

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy in adequate sedation and successful recording of EEG. Efficacy will be measured by following measures- <br/ ><br>1.Total Sleep duration <br/ ><br>2.Time from administration of the drug to adequate sedation (sleep onset latency) <br/ ><br>3.Drowsiness time <br/ ><br>4.Yield of seizure activity in the EEG <br/ ><br>5.Requirement of repeated dosing of sedative for sleep induction <br/ ><br>6.Care giverâ??s satisfaction on a Likert scale (from a scale of 1 to 5) <br/ ><br>7.Total stay time in EEG unit <br/ ><br>Timepoint: Time taken to achieve complete sedation from the point of administration of sedative drug. Sedation level will be monitored for the entire time of EEG recording of 1 hour.

Secondary Outcome Measures

Name	Time	Method
To assess the Adverse effectTimepoint: To be assessed from the point of administration of the drug to the point of complete EEG recording and till after 2 hours of the EEG recording