Clinical Trials Logo
  1. Home
  2. Procedural Anxiety
  3. NCT04586504

Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children

Procedural Anxiety Clinical Trial

Official title:
Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children

Clinical Trial Summary

Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims: Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state and time to onset of minimal sedation associated with each dose. Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.

Clinical Trial Description

Intranasal midazolam is a common and effective sedative whose use in children presenting to emergency departments has been described. However, the doses of intranasal midazolam used have varied greatly, with no identified optimal dose. Doses most commonly described in literature reviews, research studies, and clinical guidelines range from 0.2 to 0.5 mg/kg. There is only one study, retrospective, that compares doses and suggests that clinical efficacy is improved with higher doses, without any clear difference in safety. There is a need for a rigorously-conducted trial to determine the dose of intranasal midazolam that optimizes the adequacy of sedation state without leading to adverse events or compromising emergency department-centric outcomes such as time to onset of sedation and time to recovery. To fill this important and persistent gap in knowledge, the investigator will conduct a dose-finding study using an adaptive trial design to compare intranasal midazolam doses of 0.2, 0.3, 0.4, and 0.5 mg/kg in children undergoing laceration repairs, one of the most common types of minor trauma treated in emergency departments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04586504
Study type Interventional
Source Columbia University
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 8, 2021
Completion date May 14, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT04994613 - Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment N/A
Completed NCT06264960 - The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography N/A
Recruiting NCT05267704 - Evaluating the Feasibility of VR for Pediatric Renal Biopsies N/A
Completed NCT04257019 - Pain, Anxiety During Interventional Spine Procedures N/A
Terminated NCT04628052 - The Effect of Music on Colonoscopy (MUSICOL) N/A
Completed NCT04421430 - Nonpharmacological Methods for Children in Procedural Pain N/A
Not yet recruiting NCT05555498 - Virtual Reality for Anxiety and Pain Management During Oocyte Retrieval in IVF/ICSI Treatment N/A
Completed NCT05070325 - Nonpharmacological Methods for Children N/A
Completed NCT05179291 - Efficacy of VR and Buzzy on Pain and Anxiety N/A
Recruiting NCT05895383 - Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy Phase 4
Terminated NCT03043430 - Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients Phase 4
Completed NCT06018909 - The Effect of Cognitive-Behavioral Intervention Package on Procedural Pain and Anxiety in Children N/A
Not yet recruiting NCT05275621 - Virtual Reality as a Substitute to Pharmacological Sedation During PICC Placement in Pediatric Patients N/A
Recruiting NCT03740607 - Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort N/A
Completed NCT04112979 - Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW) N/A
Completed NCT05415202 - Remimazolam Sedation for Nerve Blocks
Completed NCT05974319 - The Effect of Dry Heat and Dry Cold Application on Blood Sampling in Children N/A
Completed NCT04449341 - Can Virtual Reality Reduce Pain and Anxiety During Blood Draw N/A
Active, not recruiting NCT05435105 - Effects of Virtual Reality, Cold-Vibration Due To Intravenous Catheterization on Pain, Fear and Anxiety on Children N/A
Active, not recruiting NCT05434832 - Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety N/A