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

NCT03180632 | Completed Phase 2 DMC

• 1 other identifier: JP2017
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Change of sCortisol from baseline to one hour after drug administration

  Proportion of children with a decrease of sCortisol of at least 15 points between the group Placebo and the group Lorazepam

  One hour after drug administration

Secondary Outcomes (7)

• Procedural pain

  during endoscopic procedure

• Duration of endoscopic procedure

  Through completion of endoscopy: an average of 2 hours after drug administration

• Children Satisfaction

  Through study completion, an average of 3 hours

• Physician Satisfaction

  during the endoscopic procedure

• Nurse Satisfaction

  during the endoscopic procedure

Other Outcomes (2)

• Number of participants with Treatment-related Adverse Events (Safety and Tolerability)

  during the procedure

• Change in level of sCortisol between pre-op and post-op in the group without any intervention

  Through study completion, an average of 3 hours

Study Arms (3)

Group A

ACTIVE COMPARATOR

Patient will receive a single dose of either 0,5mg or 1mg of oral Lorazepam depending on their body weight.

Drug: Lorazepam

Group B

PLACEBO COMPARATOR

Patient will receive a placebo similar in color, form and size.

Other: Placebo

Group 3

NO INTERVENTION

Patient will receive no intervention.

Interventions

Lorazepam DRUG

Patient receives one or two tablet of 0,5mg Lorazepam according to body weight

Also known as: Apo-Lorazepam

Group A

Placebo OTHER

Patient receive one of two tablet of Placebo according to body weight

Group B

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 9-18 seen in our endoscopic unit
• Children undergoing upper, lower or combined digestive endoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

• Chennou F, Bonneau-Fortin A, Portolese O, Belmesk L, Jean-Pierre M, Cote G, Dirks MH, Jantchou P. Oral Lorazepam is not Superior to Placebo for Lowering Stress in Children Before Digestive Endoscopy: A Double-Blind, Randomized, Controlled Trial. Paediatr Drugs. 2019 Oct;21(5):379-387. doi: 10.1007/s40272-019-00351-9.

  PMID: 31418168 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Prévost Jantchou, MD, PhD

  Ste-Justine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 8, 2017
• Study Start: June 28, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)