search
Back to results

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

Primary Purpose

Epilepsy, Electroencephalogram, Children

Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Melatonin
Chloral Hydrate
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring Epilepsy, Electroencephalogram, children, sedation

Eligibility Criteria

6 Months - 13 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Red Cross War Memorial Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Melatonin sleep EEG induced group

Comparison group for children sedated using previous practice

Arm Description

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) .

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2014
Last Updated
November 28, 2017
Sponsor
University of Cape Town
search

1. Study Identification

Unique Protocol Identification Number
NCT02195661
Brief Title
The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children
Official Title
The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Electroencephalogram, Children, Sedation
Keywords
Epilepsy, Electroencephalogram, children, sedation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin sleep EEG induced group
Arm Type
Active Comparator
Arm Description
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) .
Arm Title
Comparison group for children sedated using previous practice
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Type
Drug
Intervention Name(s)
Chloral Hydrate
Primary Outcome Measure Information:
Title
Efficacy of melatonin to induce sleep for EEG studies
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Breakdown data from the successful EEGs -
Description
Yield in terms of EEG abnormalities - number of abnormal studies, number of studies yielding outcomes which will alter patient management
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Comparison of EEGs performed under melatonin sedation compared to previous unit protocol
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Red Cross War Memorial Children's Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
28826048
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs