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Completed

NCT Number: NCT02195661

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Children Electroencephalogram Nervous System Diseases Sedation

Age range

6 month–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Red Cross War Memorial Children's Hospital

Cape Town, Western Cape, 7700, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

melatonin

Dietary Supplement

Chloral Hydrate

Drug

Primary outcomes

  1. Efficacy of melatonin to induce sleep for EEG studies

    Time frame: 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 outcomes

  1. Breakdown data from the successful EEGs -

    Time frame: 6 months

    Yield in terms of EEG abnormalities - number of abnormal studies, number of studies yielding outcomes which will alter patient management

Other outcomes

  1. Comparison of EEGs performed under melatonin sedation compared to previous unit protocol

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2014
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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