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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Children; Sedation; Electroencephalogram
• Intervention / Treatment: Drug: Chloral Hydrate; Dietary supplement: Melatonin

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7700
      • Red Cross War Memorial Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Cape Town

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Epilepsy; children; Electroencephalogram; sedation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Hypnotics and Sedatives; Antioxidants; Melatonin; Chloral Hydrate
• Other Study ID Numbers: 070/2014