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

University of Sao Paulo

Status and phase: Withdrawn; Phase 2

Conditions: Traumatic Brain Injury; Procedural Sedation; Computed Tomography

Treatments: Drug: Midazolam; Drug: Chloral Hydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01402596

USP-Sed-001

Details and patient eligibility

About

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.

Sex: All

Ages: 1 month to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Chloral hydrate

Active Comparator group

Description:

Children undergoing CT scanning will receive in this arm 50 mg per kg of rectal chloral hydrate.

Treatment:

Drug: Chloral Hydrate

Midazolam

Active Comparator group

Description:

Children undergoing CT scanning will receive in this arm 0,4 mg/kg of nasal midazolam.

Treatment:

Drug: Midazolam