Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam

Traumatic Brain Injury Clinical Trial

Official title:

Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam - a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01402596
• Other study ID #: USP-Sed-001
• Status: Withdrawn
• Phase: Phase 2
• First received: July 19, 2011
• Last updated: June 19, 2013
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Thousands of children receive sedation for diagnostic and therapeutic interventions annually, and this number is expected to increase. Children are at higher risk for sedation-related complications than adults. In different scenarios, multiple drugs are used to achieve sedation, each one with particular adverse events that must be monitored and reported.

Children that need CT scans for traumatic brain injuries often need sedation, without needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low incidence of adverse events; however, despite its worldwide use, it's being abandoned due to bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam, on the other hand, produces high and fast concentrations on CSF with greater rates of success but probably with higher adverse events. There are no prospective studies with large series of patients using intranasal midazolam.

The aim of this study is to determine if nasal midazolam is a safer approach and more effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT scans.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 3 Years

Eligibility

Inclusion Criteria:

• children undergoing CT scanning for TBI

Exclusion Criteria:

• epistaxis

• suspected or confirmed skull or nasal fracture

• Moderate to severe traumatic brain injury

• hemodynamically unstable

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Computed Tomography
• Procedural Sedation
• Traumatic Brain Injury

Intervention

Drug:
• Midazolam
0,4 mg per kg - intranasal midazolam - once
• Chloral Hydrate
50 mg per kg, rectal

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Such as hypoxemia, respiratory depression, vomiting, hypotension	Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours	Yes
Secondary	Efficacy of both drugs	Patients vital signs and adverse events will be monitored through patient stay in the emergency department. Mean time after sedation is about three hours.; Variables collected include Ramsay score for sedation. To consider hospital discharge, we will try to validate Aldrette score and compare the scores between the two arms. Mean time to onset of sedation and time of emergency department stay will also be compared as a mark of efficacy of these two drugs.	Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours	Yes