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

Sponsor

University of Cape Town (Other)

Overall Status

Completed

CT.gov ID

NCT02195661

Collaborator

(none)

194

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Electroencephalogram Children Sedation	Dietary Supplement: Melatonin Drug: Chloral Hydrate	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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) .	Dietary Supplement: Melatonin
Other: Comparison group for children sedated using previous practice Since the choral hydrate had been withdrawn a direct comparison group was not possible.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.	Drug: Chloral Hydrate

Arm

Intervention/Treatment

Active Comparator: 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) .

Dietary Supplement: Melatonin

Other: 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.

Drug: Chloral Hydrate

Outcome Measures

Primary Outcome Measures

Efficacy of melatonin to induce sleep for EEG studies [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 Outcome Measures

Breakdown data from the successful EEGs - [6 months]
Yield in terms of EEG abnormalities - number of abnormal studies, number of studies yielding outcomes which will alter patient management

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.