| City: |
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Seattle |
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State:
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WA |
| Zip Code: |
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98105 |
| Conditions: |
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Anxiety |
| Purpose: |
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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., explanations, 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.
In view of these recent developments, 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. Reducing the
stress of laceration repair can have lasting effects on a child's perception of medical
treatment in general, improving future interactions with health care professionals. In
addition, by increasing the child's ability to cooperate, practitioners will be better able
to repair these wounds properly and efficiently.
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| Study summary: |
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The goal of this study is to improve sedation of children undergoing laceration repair in
the emergency department. Currently, children who require sedation for laceration repair
most often receive short acting benzodiazepines (i.e.,midazolam) orally (by mouth). Studies
on the effectiveness of oral midazolam for minor procedures cite a 50-75% success rate.
Oral midazolam has variable effectiveness and onset of action, and due to first pass hepatic
metabolism, oral midazolam has a bioavailability of only 27% in children (Blumer 1998).
Given the low success rate of oral midazolam, administration via mucous membranes has also
been attempted. When administered intranasally or buccally, midazolam has a much higher
bioavailability (Walberg 1991) and more rapid onset of action. Unfortunately, when given by
these routes in previous studies, it was dripped into the nose or placed under the tongue.
This leads to either swallowing the liquid drug, or expelling it, leading again to
suboptimal bioavailability. Moreover, intranasal midazolam is irritating to the nasal mucosa
and has therefore not always been well tolerated. When given to cooperative adults,
midazolam dripped onto mucosal surfaces can have a bioavailability of approximately 75%
(Schwagmeier 1998).
It has been hypothesized that better distribution of midazolam on mucosal surfaces would
improve the reliability and effectiveness of this route of administration. A device called
an atomizer has been developed for just this purpose (Wolfe Tory Medical, Inc., Salt Lake
City, UT). The atomizer is an attachment on the end of a small syringe that causes the
medication to be propelled over a larger surface area in a spray (see Figure below). This
allows a greater percentage of the medication to be absorbed via the mucosal surface with a
direct route to the blood stream leading to faster and more reliable onset of action, while
avoiding the problem of hepatic metabolism that occurs with enterally absorbed midazolam.
We propose a study to determine if changes in the mode of administration and dosing of
midazolam can provide improved sedation for children undergoing anxiety-producing
procedures, without adversely effecting safety, length of stay, or patient/family and staff
satisfaction.
To study this, we propose a randomized clinical trial to compare three methods of
administering midazolam for sedation: oral midazolam 0.5 mg per kg, buccal midazolam 0.3 mg
per kg and intranasal midazolam 0.3 mg per kg. The subject population will be children
under the age of 7 who require sedation for laceration repair in the Emergency Department of
Children's Hospital and Regional Medical Center. Patients will be excluded if they have:
closed head injury with loss of consciousness, abnormal neurologic exam relative to baseline
status, severe developmental delay or baseline neurologic deficits, severe trauma with
suspected internal injuries, acute or chronic respiratory conditions, or renal, cardiac or
hepatic abnormalities.
Variables of interest will include level of sedation prior to and during the procedure
(using an activity scale and a modified CHEOPS scale) (McGrath 1985), time to adequate
sedation, procedure length, length of ED stay, parental, MD, and RN satisfaction using a
Likert scale, and complications such as respiratory depression and vomiting as well as
measures needs to ameliorate those complications. For adequate power, we anticipate
enrolling 180 patients (60 in each treatment group) during the 24-month duration of the
study. |
| Criteria: |
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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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
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above to view all information about this clinical trial. |
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