Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy:

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of a single dose of Lorazepam on salivary cortisol in children undergoing digestive endoscopy. To do so, the patients will be randomized in three groups. The first group receives the Lorazepam, the second group receives a placebo and the last group receives no intervention. Each patient will have three saliva samples taken at three different time point on the day of the endoscopy and will be asked to fill out questionnaires on anxiety and overall satisfaction of the procedure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Justine's Hospital
• Treatments: Hydrocortisone; Lorazepam

Criteria

Inclusion Criteria:

• Children aged 9-18 seen in our endoscopic unit

• Children undergoing upper, lower or combined digestive endoscopy

• Procedure to be performed within 3 hours of inclusion in the study and drug administration

Exclusion Criteria:

• Unable to read or speak English or French

• Diagnosed with a psychiatric or neurological disorder

• Myasthenia gravis

• Acute narrow angle glaucoma

• Known hypersensitivity to benzodiazepines

• Already treated with an anxiolytic on a regular basis

• Receiving a drug contraindicated in association with benzodiazepines

• Receiving oral, intravenous or inhaled corticosteroids in the last two days before randomization

• Body weight less than 20 kg

• Pregnancy