Cyclopentolate induced EEG changes in children

Cyclopentolate is the most frequently used cycloplegic eye-drops in children.
About 10% of the subjects suffer from side effects (SE). These SE almost
exclusively involve the central nervous system (CNS). The risk for SE increases
with younger age and in the presence of low BMI. The most frequently reported
SE is drowsiness and hyperactivity. CNS changes can be recorded by EEG. There
are no studies describing EEG changes after cyclopentolate. There however
studies describing EEG changes after IV administration of atropine. The nature
and severity of the changes are dose dependent. A pilot study in 2 young normal
BMI children showed EEG changes in both subjects after 2 drops of
cyclopentolate 1% and no changes after no drops. Most of the children receiving
cyclopentolate are young. There is evidence that BMI distribution is shifting
towards outer limits. The purpose of this study is to gain more insight in the
presence and nature of CNS changes after cyclopentolate. A scientific base is
present and EEG recording is proven to be a sensitive method to demonstrate
these changes.

Amendement
Because of the presence of sinus rhythm changes in 3 of the 5 included
subjects, this study is extended with an ECG. A scientific base is present.
The purpose of the ECG assessment is to gain insight in the presence and nature
of ECG changes after cyclopentolate.

To compare the EEG pattern after administration of cyclopentolate with the EEG
pattern after placebo eye-drops.

Primary outcome
EEG pattern changes after administration of two drops of cyclopentolate1%
compared with placebo.

Secondary outcomes
- Pattern changes EEG
- Time of onset of EEG changes
- Frequency of EEG changes
- Factors (e.g. age, BMI etc.) that influences onset of- and/or changes in EEG
pattern.

- Pattern changes ECG
- Time of onset of ECG changes

This investigator initiated study is designed as a prospective, single-centre,
cross sectional, quantitative, randomized, single-blind placebo-controlled
observational study.

This study investigates the presence, nature and severity of central nervus
system changes with EEG recording and investigate risk factors for onset of
central nervus system changes after administration of two drops of
cyclopentolate 1%. The duration of the study will be approximately 12 months.

Intervention:

Randomized
• Two drops of cyclopentolate hydrochloride 1%, with an interval of 5
minutes in both eyes
or
• Placebo:

Risk and burden:
There are no additional risks present since subjects are already planned for a
routine cycloplegic refractive assessment according to their treatment or
standard departmental follow-up. There are no risk involved in the EEG or ECG
registration nor application of the EEG or ECG electrodes. The additional
application of the placebo eye-drops provide a small burden. The placebo
eye-drop is very child friendly and does not sting or burn. Eventual discomfort
of feeling the liquid in the eye is of a very short duration. Inconvenience
will mainly consist of the additional visit, the limitation of staying on a bed
for 50 minutes and extra washing hair after each EEG recording.

Benefit and group relatedness:
The results will lead to insight in the onset, nature and extensiveness of
central changes due to cycloplegics. Factors involved in the onset of central
adverse events will be determined. Results can be extrapolated to the general
population and will be translated to an optimal method e.g. intervention for
obtaining objective refraction in children.