The purpose of this study is to identify the incidence of scratches on the surface of the eye in children who can not blink due to medication use and to identify how best to reduce the risk of a scratch on the surface of the eye when patients are using specific medicines.

Condition	Intervention
Corneal abrasions	Procedure: plastic wrap over eye w/lubrication applied Q6hrs

Further Study Details: 

Primary Outcomes: Development of corneal abrasions
Secondary Outcomes: Incidence of corneal abrasions
Expected Total Enrollment:  206

Critically ill children may require neuromuscular blockade as a treatment modality. These children require careful eye care to prevent corneal abrasions. However, current evidence does not exist to guide best practices on eye care. This research study will evaluate 2 types of eye care therapy. The eyes will be randomly assigned to the control or experimental eye care therapy group. The control eye will receive lubricating ointment every 6 hours. The experimental eye will receive lubricating ointment every 6 hours and have a plastic covering to create a moisture chamber. Using daily fluoroscein staining to detect corneal abrasions, each child will be studied for up to 9 days. Children who develop corneal abrasions will be discharged from the study and the primary care team will be notified. The two groups will then be compared to determine the therapy associated with the lowest incidence of corneal abrasions.

Ages Eligible for Study:  up to  17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age greater than 42 weeks post-conceptual age and less than 18 years;
• Anticipated need for neuromuscular blockade therapy for at least 24 hours.

Exclusion Criteria:

• Use of continuous neuromuscular blockade therapy for more than 36 hours (early intervention study);
• Past medical history of abnormal blink reflex or incomplete lid closure;
• History of daily eye drops use;
• Facial trauma;
• Alteration in periorbital skin integrity prohibiting eyelid closure or effective creation of a moisture chamber;
• Known allergy to eye lubricant;

Please refer to this study by ClinicalTrials.gov identifier  NCT00129077

Lauren Sorce, MSN      773-975-8834    Lsorce@childrensmemorial.org
Susan Hamilton-Bruno, MSN      617-355-2990    Susan.Hamilton-Bruno@childrens.harvard.edu

Illinois
      Children''''s Memorial Hospital, Chicago,  Illinois,  60614,  United States; Recruiting
Massachusetts
      Children''''s Hospital Boston, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Martha AQ Curley, PhD,  Study Chair,  Children''''s Hospital Boston   

Study ID Numbers:  2003-12005
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129077
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23