Status:
COMPLETED
The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children
Lead Sponsor:
University of Cape Town
Conditions:
Epilepsy
Electroencephalogram
Eligibility:
All Genders
6-13 years
Phase:
PHASE3
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 us...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT02195661
Start Date
April 1 2014
End Date
October 1 2017
Last Update
November 30 2017
Active Locations (1)
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1
Red Cross War Memorial Children's Hospital
Cape Town, Western Cape, South Africa, 7700