Recruitment

Recruitment Status
Completed
Estimated Enrollment
128

Inclusion Criterias

1 to 7 years of age, inclusive.
Require intranasal midazolam for minimal sedation to facilitate laceration repair.
1 to 7 years of age, inclusive.
Require intranasal midazolam for minimal sedation to facilitate laceration repair.

Exclusion Criterias

Weight less than 10 kg.
Foster children or wards.
Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
...
Weight less than 10 kg.
Foster children or wards.
Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
Developmental delay, psychiatric illness, neurologic impairment, or altered mental status; or illnesses associated with chronic pain (e.g. sickle cell disease, inflammatory bowel disease).
Inability to speak English or Spanish
Known allergy to midazolam.

Summary

Conditions
Children Requiring Sedation to Facilitate Laceration Repair
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 1 years and 7 years
Gender
Both males and females

Description

The intranasal route is an effective means of administering sedative medications for children. However, sometimes the child has to receive a certain dose that requires a very large volume to be administered into the nose, because of the types of concentrations of drugs that are available. Most drugs...

The intranasal route is an effective means of administering sedative medications for children. However, sometimes the child has to receive a certain dose that requires a very large volume to be administered into the nose, because of the types of concentrations of drugs that are available. Most drugs are not concentrated enough so that small volumes can be consistently given, so as a result, sometimes a very large amount of medication is administered intranasally. When the amount is too large, most of the medication either runs back out the nose, or down the back of the nose and throat and is swallowed, instead of being absorbed in the nasal cavity, where it can be quickly absorbed and produce optimal effectiveness.

Inclusion Criterias

1 to 7 years of age, inclusive.
Require intranasal midazolam for minimal sedation to facilitate laceration repair.
1 to 7 years of age, inclusive.
Require intranasal midazolam for minimal sedation to facilitate laceration repair.

Exclusion Criterias

Weight less than 10 kg.
Foster children or wards.
Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
...
Weight less than 10 kg.
Foster children or wards.
Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
Developmental delay, psychiatric illness, neurologic impairment, or altered mental status; or illnesses associated with chronic pain (e.g. sickle cell disease, inflammatory bowel disease).
Inability to speak English or Spanish
Known allergy to midazolam.

Locations

New York, New York, 10032
New York, New York, 10032

Tracking Information

NCT #
NCT01948908
Collaborators
Not Provided
Investigators
  • Principal Investigator: Daniel S Tsze, MD, MPH Columbia University
  • Daniel S Tsze, MD, MPH Columbia University