What is the mechanism of action of this treatment?

Intranasal Dexmedetomidine, an alpha-2 adrenergic agonist, works by activating alpha-2 receptors in the brain, leading to sedation, anxiolysis, and analgesia without significant respiratory depression. Intranasal Midazolam, a benzodiazepine, enhances the effect of the neurotransmitter GABA, resulting in sedation, anxiolysis, and muscle relaxation. Nitrous Oxide, an inhaled anesthetic, provides rapid onset analgesia and sedation by modulating NMDA receptors and releasing endogenous opioids. These treatments are crucial for skin laceration patients as they reduce anxiety, pain, and distress during the procedure, improving patient comfort and cooperation.

What side effects are associated with this type of intervention?

Intranasal Dexmedetomidine, an alpha-2 adrenergic agonist, can cause side effects such as bradycardia, hypotension, dry mouth, and sedation. Intranasal Midazolam, a benzodiazepine, may lead to drowsiness, dizziness, respiratory depression, and paradoxical reactions like agitation or aggression. Nitrous Oxide, an inhaled anesthetic, is generally well-tolerated but can cause nausea, vomiting, dizziness, and in rare cases, hypoxia or neuropathy with prolonged use. Patients should discuss these potential side effects with their healthcare provider to determine the most appropriate treatment for their condition.

What prior FDA approvals exist?

The FDA has approved various treatments for managing pain and anxiety during skin laceration repairs. Intranasal midazolam, a benzodiazepine, is commonly used for its sedative and anxiolytic effects. Nitrous oxide, an inhaled anesthetic, is also approved and widely used for its rapid onset and ease of administration, providing both analgesia and sedation. While intranasal dexmedetomidine, an alpha-2 adrenergic agonist, is not specifically mentioned in the context of skin lacerations, it is known for its sedative properties and is used in other procedural settings. These treatments aim to reduce distress and improve patient comfort during minor surgical procedures.

What other types of research exist?

Promising novel alternatives for treating skin lacerations in 2024 include oral gabapentin, which has shown efficacy in reducing preoperative anxiety and pain, and perioperative pregabalin, which has been effective in reducing pain, anxiety, and enhancing sleep quality. Additionally, low-dose ketamine, known for its analgesic properties, and dexamethasone, which has been effective in reducing postoperative pain, are also potential alternatives.

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Alpha-2 Adrenergic Agonist

Sedatives for Anxiety with Lacerations in Children (ALICE Trial)

Phase 3

Recruiting

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from drug administration to discharge (80 minutes)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests three ways to help calm children during stitches: two nose sprays (dexmedetomidine and midazolam) and a gas (nitrous oxide). It focuses on children who need stitches because they often feel very distressed. These methods work by making children feel sleepy or reducing their pain. Dexmedetomidine has been studied for its effectiveness in reducing agitation after tonsillectomy in children.

Who is the study for?

This trial is for children aged 2 to nearly 13 years who need stitches for a single cut and don't require heavy sedation. The child or caregiver must want mild sedation, which will be given alongside local anesthesia. Kids with certain heart rates or blood pressure issues, suspected pregnancy, inability to express pain, language barriers without an interpreter, over 65 kg in weight, not healthy or with controlled disease only (ASA class I/II), drug allergies or recent sedatives can't join.

What is being tested?

The study tests three light sedatives: dexmedetomidine and midazolam as nasal sprays, and nitrous oxide gas. It aims to find the best one for calming kids during stitch application after cuts. Children are randomly assigned to receive one of these treatments and their distress levels are measured using the OSBD-R scale.

What are the potential side effects?

Possible side effects include sleepiness, slower heart rate from dexmedetomidine; drowsiness or mood changes from midazolam; nausea or dizziness from nitrous oxide. Each medication has specific risks that depend on individual health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from drug administration to discharge (80 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from drug administration to discharge (80 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from drug administration to discharge (80 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Observational Scale of Behavioral Distress - Revised (OSBD-R)

Secondary study objectives

Adverse effects

Late maladaptive behaviors

Need for additional anxiolysis or sedation to facilitate repair

+1 more

Other study objectives

Caregiver satisfaction with anxiolysis during laceration repair

Caregiver state anxiety

Child satisfaction with anxiolysis during laceration repair

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Intranasal midazolamExperimental Treatment1 Intervention

IN midazolam 0.4 mg/kg \[5 mg/mL (max 10 mg or 2 mL)\]

Group II: Intranasal dexmedetomidineExperimental Treatment1 Intervention

IN dexmedetomidine 3 mcg/kg \[100 mcg/mL (max 200 mcg or 2 mL)\]

Group III: Inhaled nitrous oxideExperimental Treatment1 Intervention

50% N2O in 50% oxygen by face mask or on-demand system

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine

2015

Completed Phase 4

~2050

Nitrous oxide

2007

Completed Phase 4

~990

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intranasal Dexmedetomidine, an alpha-2 adrenergic agonist, works by activating alpha-2 receptors in the brain, leading to sedation, anxiolysis, and analgesia without significant respiratory depression. Intranasal Midazolam, a benzodiazepine, enhances the effect of the neurotransmitter GABA, resulting in sedation, anxiolysis, and muscle relaxation. Nitrous Oxide, an inhaled anesthetic, provides rapid onset analgesia and sedation by modulating NMDA receptors and releasing endogenous opioids. These treatments are crucial for skin laceration patients as they reduce anxiety, pain, and distress during the procedure, improving patient comfort and cooperation.

Oral medication with diazepam or midazolam associated or not with clonidine for oculoplastic office surgery under local anesthesia.Dexmedetomidine: sedation, analgesia and beyond.