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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195661
• Other study ID #: 070/2014
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2014
• Last updated: November 28, 2017
• Start date: April 2014
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Electroencephalogram
• Epilepsy
• Sedation

Intervention

Dietary Supplement:
• Melatonin

Drug:
• Chloral Hydrate

Locations

Country	Name	City	State
South Africa	Red Cross War Memorial Children's Hospital	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

Ibekwe R, Jeaven L, Wilmshurst JM. The role of melatonin to attain electroencephalograms in children in a sub-Saharan African setting. Seizure. 2017 Oct;51:87-94. doi: 10.1016/j.seizure.2017.08.002. Epub 2017 Aug 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of EEGs performed under melatonin sedation compared to previous unit protocol	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.	6 months
Primary	Efficacy of melatonin to induce sleep for EEG studies	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)	6 months
Secondary	Breakdown data from the successful EEGs -	Yield in terms of EEG abnormalities - number of abnormal studies, number of studies yielding outcomes which will alter patient management	6 months