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

NCT ID: NCT02195661

Last Updated: 2017-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-10-31

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.

Conditions

Epilepsy; Electroencephalogram; Children; Sedation

Keywords

Epilepsy; Electroencephalogram; children; sedation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Melatonin sleep EEG induced group

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. Melatonin by mouth (3mg for children \< 15kg, 6mg for those \> 15kg) 1 hour before the scheduled EEG by the unit nurse. Children who can swallow the capsules directly, those who cannot are given the contents of the powder in the capsule mixed in a few millilitres of water. If the child fails to fall asleep within one hour of administration of the melatonin then a second dose 3mg is given) .

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Comparison group for children sedated using previous practice

Since the choral hydrate had been withdrawn a direct comparison group was not possible. However a study performed the previous year in the department measured a several parallel useful outcomes. This study had addressed the usefulness of electroencephalograms in a South African population. A proportion of this group screened in 2012 in our unit underwent sleep studies, sedated with chloral (n=22). These patients were drawn from the same regional pool, with the same disease demographics, and the same sleep deprivation and procedural techniques to the current group. This group was screened for several common denominators to the current study themes, and comparison will be made between these, namely the proportion of patients with successful attainment of sleep studies, the proportion of studies with excessive artifact (precluding interpretation) and the usefulness of the data attained detailing whether the studies were able to assist or alter patient management.

Group Type: OTHER

Chloral Hydrate

Intervention Type: DRUG

Interventions

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Chloral Hydrate

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Jo M Wilmshurst

Professor Jo Wilmshurst

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Red Cross War Memorial Children's Hospital

Cape Town, Western Cape, South Africa

Countries

South Africa

References

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.

Reference Type: BACKGROUND

PMID: 28826048 (View on PubMed)

Other Identifiers

070/2014

Identifier Type: -

Identifier Source: org_study_id