The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cape Town
• Treatments: Chloral Hydrate; Melatonin

Criteria

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.