Anxiety Clinical Trial
Official title:
Improving Sedation of Children Undergoing Procedures in the Emergency Department: Evaluation of Different Dosages and Routes of Administration of the Sedative Midazolam
NCT number | NCT00675909 |
Other study ID # | 2005-0260A |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2006 |
Est. completion date | January 2010 |
Verified date | November 2018 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Lacerations (deep cuts) are a frequent cause of visits to emergency departments and
laceration repair is one of the most common procedures performed in that setting. Children
are often anxious when they visit the emergency department, and visits where they anticipate
needing painful procedures can be particularly stressful. Though we can manage the pain
associated with many minor procedures, we are frequently unable to adequately support the
child and treat their problem if we don't manage their anxiety as well. Methods of calming
that do not require medication (e.g. distraction, parental support) can help, but many
patients still require sedative medications.
The goal of sedation in the pediatric emergency department is to relieve the child's anxiety
while minimizing the risk of adverse events. Unfortunately, when sedative medications are
used in doses that do not slow breathing, they often fail to manage the child's anxiety
adequately. In addition, many sedative agents require the placement of an intravenous line,
which is itself a painful procedure that can create, rather than relieve, anxiety.
Currently, there is no ideal sedative agent that is safe, effective, and easy to administer.
Oral midazolam is one of the most commonly used sedative medications for laceration repair in
children. In a dose of 0.5mg/kg it has been shown to be safe. Unfortunately, it provides
adequate sedation in only about two thirds of patients and has a delayed onset of up to 20
minutes. The remaining children must either endure the procedure in an agitated state or
suffer placement of an intravenous line to administer additional sedative medications.
We aim to find a method of providing sedation for laceration repair that has a higher success
rate than oral midazolam as currently prescribed without increasing the risk of
complications. We would like to evaluate new methods for administering midazolam using
alternate routes and dosages. Previous studies have looked at the use of midazolam absorbed
directly by mucous membranes such as inside the nose (intranasal) and inside the mouth
(buccal). The use of intranasal midazolam has had some success especially given its rapid
onset of action (about 5 minutes), but has been limited by the irritant effects of the drug.
When placed in the mouth, many children swallow the drug or spit it out rather than allowing
it to be absorbed by the mucous membrane. There has been some improved success when the drug
was placed under the tongue, but this is typically difficult for young children. However, a
new device called an "atomizer" has been developed that allows for improved intranasal and
buccal administration. The "atomizer" has a small adapter placed on the end of a syringe,
which spreads the medication out in a fine mist over a wide area. It can be sprayed in the
mouth inside the cheek (buccal), avoiding the need to keep the medication under the tongue.
While some pediatric institutions have already started giving midazolam with the atomizer,
and are reporting anecdotal success with these methods, its safety and effectiveness have not
been rigorously studied.
We propose to compare three approaches to sedation: commonly used doses of oral midazolam,
atomized intranasal midazolam and atomized intraoral midazolam. Children under the age of 7
requiring sedation for wound repair will be eligible for enrollment. After informed consent,
children will be randomized to one of the three methods described above. Their level of
sedation will be determined using two scores validated for use in children (the sedation
score and the modified CHEOPS score). Physician, nurse and parent impressions of sedation
will also be compared.
By comparing our current approach to these new methods, we will be able to determine which
method is best. If we can identify a method for administering the sedative drug midazolam
that is safe, well tolerated, and more effective, we will have made a valuable and important
contribution to the care of injured children in the emergency department.
Status | Completed |
Enrollment | 180 |
Est. completion date | January 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 7 Years |
Eligibility |
Inclusion Criteria: 1. Laceration in need of repair with sutures, with no other major injuries 2. Age >=6 months and < 7 years 3. No meal within the last 2 hours Exclusion Criteria: 1. Closed head injury associated with loss of consciousness 2. Abnormal neurologic exam, relative to baseline status 3. Significant developmental delay or baseline neurologic deficit 4. Severe trauma with suspected internal injuries 5. Acute or chronic respiratory condition 6. Acute or chronic renal, cardiac or hepatic abnormalities 7. Allergy to benzodiazepines or previous reaction to benzodiazepines 8. Taking erythromycin containing antibiotics 9. Nasal and intraoral lacerations |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital |
Klein EJ, Brown JC, Kobayashi A, Osincup D, Seidel K. A randomized clinical trial comparing oral, aerosolized intranasal, and aerosolized buccal midazolam. Ann Emerg Med. 2011 Oct;58(4):323-9. doi: 10.1016/j.annemergmed.2011.05.016. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair). | Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation. Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3). |
Baseline (presentation, before sedation) in ED to start of procedure (laceration repair). | |
Secondary | Time From Study Drug Administration to Start of Procedure | Time from study drug administration to start of procedure up to 68 minutes | ||
Secondary | Duration of Procedure | Duration of procedure up to 40 minutes | ||
Secondary | Physician Rating of Sedation | Range is 0-10. Higher is associated with physician impression that sedation is better. | Physician was asked after the procedure was done about their impression of sedation. | |
Secondary | Nurse Rating of Sedation | Range is 0-10. Higher is associated with nurse impression that sedation is better. | After the procedure nurse was asked about their impression of the level of sedation. |
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