Intranasal Medications for Anxiety During Pediatric Procedures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests three different nose sprays—Intranasal Midazolam, Intranasal Dexmedetomidine, and Intranasal Ketamine—to determine which best calms young children during stitches. The study examines how quickly children can leave the emergency room and the satisfaction levels of both children and doctors with the treatment. Children aged 1 to 5 who need stitches for small cuts (5 cm or less) and whose caregivers speak English may qualify for this trial. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, providing an opportunity to assess their benefits for more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are taking beta blockers or any other blood pressure lowering agents, you cannot participate in the trial.
What is the safety track record for these treatments?
Research shows that the three nasal spray medications being studied—Dexmedetomidine, Ketamine, and Midazolam—have been safely used in children for various procedures.
Studies have found that nasal Dexmedetomidine safely calms children during procedures. It works effectively with few side effects, though high doses can cause low blood pressure and a slow heart rate.
Nasal Ketamine is also safe and effective for reducing anxiety in children. Most studies report successful calming effects, though some children experienced mild side effects like vomiting.
Nasal Midazolam is commonly used for simple procedures in kids. It is usually well-tolerated, but it can sometimes cause breathing problems and low blood pressure.
Overall, these medications have a good safety record in children, with studies supporting their use in procedures similar to those in the current trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these intranasal treatments for anxiety during pediatric procedures because they offer a unique delivery method that could make medication administration easier for kids and healthcare providers. Intranasal Dexmedetomidine, Ketamine, and Midazolam bypass the need for needles, which can be particularly beneficial for children who are already anxious. Unlike standard oral or intravenous methods, these treatments could provide rapid onset and effective anxiolysis without the discomfort and distress associated with more invasive procedures. Each medication has its distinct benefits: Dexmedetomidine and Ketamine have shown effectiveness in sedation and anxiolysis in prior studies, while Midazolam is already a staple in pediatric care for minimal procedures. This trial explores whether these intranasal options can enhance patient comfort and procedural success in emergency settings.
What evidence suggests that this trial's intranasal medications could be effective for anxiety during pediatric procedures?
This trial will compare the effectiveness of different intranasal medications for calming children during procedures. Research has shown that a nasal spray with dexmedetomidine, one of the treatments in this trial, safely and effectively calms children, with 92% successfully calmed without major side effects. Another treatment option, nasal spray with ketamine, has also shown promise; studies indicate it effectively calmed 60% of children, with most parents satisfied with the results. Nasal spray with midazolam, also tested in this trial, is known to reduce anxiety and provide moderate calming, though some children find it irritating to the nose. Each treatment has proven effective in managing anxiety and discomfort during procedures for children.16789
Who Is on the Research Team?
Ryan Mckee, MD
Principal Investigator
University of Oklahoma
Are You a Good Fit for This Trial?
This trial is for children aged 1-5 who need stitches for small cuts (up to 5cm) and are in the emergency department. Their parents or caregivers must speak English. It's not clear what conditions exclude someone from participating.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intranasal Midazolam, Dexmedetomidine, or Ketamine for anxiolysis during minimal procedures in the pediatric emergency department
Follow-up
Participants are monitored for safety and effectiveness after treatment, including anxiety levels and satisfaction
What Are the Treatments Tested in This Trial?
Interventions
- Intranasal Dexmedetomidine
- Intranasal Ketamine
- Intranasal Midazolam
Intranasal Dexmedetomidine is already approved in United States, European Union, Canada for the following indications:
- Sedation of adult patients requiring monitored anesthesia care in outpatient settings
- Sedation of adult patients requiring sedation prior to diagnostic or surgical procedures
- Sedation of pediatric patients requiring sedation for diagnostic or therapeutic procedures
- Sedation of adult intensive care unit (ICU) patients requiring a sedation level not deeper than arousal in response to verbal command
- Sedation of adult patients requiring sedation prior to diagnostic or surgical procedures
- Sedation of adult patients requiring monitored anesthesia care in outpatient settings
- Sedation of adult patients requiring sedation prior to diagnostic or surgical procedures
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor