Epilepsy, Electroencephalogram, Children, Sedation
Conditions
Keywords
Epilepsy, Electroencephalogram, children, sedation
Brief summary
This study aims to determine the safety and effectiveness of oral melatonin as natural inducer of sleep to acquire useful EEGs in South African children following its introduction as the main agent used in the Neurophysiology department at Red Cross Children's Hospital. This is an observational retrospective study.
Interventions
DIETARY_SUPPLEMENTMelatonin
DRUGChloral Hydrate
Sponsors
University of Cape Town
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 13 Years
Healthy volunteers
No
Inclusion criteria
* All children who were referred to the neurophysiology department who were either unable to keep still for their EEG, or required a sleep EEG as part of their epilepsy work-up and whose caregivers agreed to the administering of sedation with melatonin.
Exclusion criteria
* Those children undergoing prolonged EEG monitoring (telemetry) or within 24 hours of status epilepticus (prolonged or cluster of seizures). * Those children are not sedated as natural sleep is always attained with the prolonged monitoring studies, and for those with status epilepticus, there is usually evidence on the EEG of alteration secondary to the effects of status, and the medications administered to control the presenting event. * Any child deemed to unwell to undergo a non-emergency procedure. * Any child already receiving anticoagulant medications. * Any caregiver who deferred sedation for their child was also excluded from the study and in the unit the procedure attempted without sedation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of melatonin to induce sleep for EEG studies | 6 months | Successful attainment of EEG (in comparison to the unit's previous success rate)(Definition: successful attainment of EEG = completed sleep EEG, without excessive artefact enabling an comprehensive report to be generated in a child who undergoes the procedure without evidence of adverse drug reactions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breakdown data from the successful EEGs - | 6 months | Yield in terms of EEG abnormalities - number of abnormal studies, number of studies yielding outcomes which will alter patient management |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of EEGs performed under melatonin sedation compared to previous unit protocol | 6 months | To compare the EEG recordings in comparison to a historical group of age matched recordings sedated with chloral and to establish if the outcomes achieved are in line with the previous unit practice. |
Countries
South Africa
Outcome results
None listed