Health Condition 1: G968- Other specified disorders of central nervous system
Conditions
Interventions
Intervention1: Sedative Drugs: The purpose of this study is to compare efficacy and safety of 4 sedative drugs such as Triclofos (TL), promethazine (PZ), hydroxyzine (HZ) and melatonin (ML) for sedati
Sponsors
Leeha Singh principal investigator
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy in adequate sedation and successful recording of EEG. Efficacy will be measured by following measures- 1.Total Sleep duration 2.Time from administration of the drug to adequate sedation (sleep onset latency) 3.Drowsiness time 4.Yield of seizure activity in the EEG 5.Requirement of repeated dosing of sedative for sleep induction 6.Care giverâ??s satisfaction on a Likert scale (from a scale of 1 to 5) 7.Total stay time in EEG unit 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactLEEHA SINGH
B. J. Wadia Hospital for Children
Outcome results
None listed