Improving Sedation of Children Undergoing Procedures in the Emergency Department

NCT00675909 | Completed Results DMC

• 1 other identifier: 2005-0260A
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anxiety

Keywords

Sedation; Anxiety; Minor procedures; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time From Study Drug Administration to Start of Procedure

  Time from study drug administration to start of procedure up to 68 minutes

• Duration of Procedure

  Duration of procedure up to 40 minutes

• Physician Rating of Sedation

  Physician was asked after the procedure was done about their impression of sedation.

• Nurse Rating of Sedation

  After the procedure nurse was asked about their impression of the level of sedation.

Study Arms (3)

Oral Midazolam

ACTIVE COMPARATOR

Oral midazolam 0.5mg/kg

Drug: Oral midazolam

Aerosolized intranasal midazolam

EXPERIMENTAL

Intranasal midazolam 0.3mg/kg

Drug: Aerosolized Intranasal midazolam

Aerosolized buccal midazolam

EXPERIMENTAL

Buccal midazolam 0.3mg/kg

Drug: Aerosolized Buccal Midazolam

Interventions

Aerosolized Intranasal midazolam DRUG

Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg.

Also known as: Versed

Aerosolized intranasal midazolam

Aerosolized Buccal Midazolam DRUG

0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth.

Also known as: Versed

Aerosolized buccal midazolam

Oral midazolam DRUG

oral midazolam 0.5mg/kg

Also known as: Versed

Oral Midazolam

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Laceration in need of repair with sutures, with no other major injuries
• Age \>=6 months and \< 7 years
• No meal within the last 2 hours

You may not qualify if:

• Closed head injury associated with loss of consciousness
• Abnormal neurologic exam, relative to baseline status
• Significant developmental delay or baseline neurologic deficit
• Severe trauma with suspected internal injuries
• Acute or chronic respiratory condition
• Acute or chronic renal, cardiac or hepatic abnormalities
• Allergy to benzodiazepines or previous reaction to benzodiazepines
• Taking erythromycin containing antibiotics
• Nasal and intraoral lacerations

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Related Publications (1)

• 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.

  PMID: 21689865 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Emergencies

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Eileen Klein, MD, MPH
• Organization: Seattle Children's Hospital

eileen.klein@seattlechildrens.org

206-987-2599

Study Officials

• Eileen J Klein, MD, MPH

  Associate Professor, Pediatrics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 12, 2008
• Study Start: November 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: November 9, 2018
• Results First Posted: June 7, 2012

Record last verified: 2018-11