Sedatives for Anxiety with Lacerations in Children
(ALICE Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Must not be taking: Sedatives, Anxiolytics, Alpha-2 agonists
Disqualifiers: Pregnancy, Renal insufficiency, Psychosis, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that participants do not take any sedative, anxiolytic, or alpha-2-adrenergic receptor agonist within 24 hours before the intervention. This means you may need to stop certain medications that fall into these categories before participating.
What data supports the effectiveness of the drug for anxiety in children with lacerations?
Research shows that intranasal midazolam and dexmedetomidine are effective in reducing anxiety in children during medical procedures. Midazolam is known for its calming effects, while dexmedetomidine is safe and effective when used with nitrous oxide for sedation.
12345Is the combination of sedatives like dexmedetomidine, midazolam, and nitrous oxide safe for children?
Studies suggest that using dexmedetomidine or midazolam with nitrous oxide is generally safe for children, with no major adverse events reported. Some children experienced minor issues like low blood pressure or increased heart rate, but these did not require medical intervention.
13678How does this drug differ from other treatments for anxiety in children with lacerations?
This treatment is unique because it combines intranasal dexmedetomidine and midazolam, which are both effective in reducing anxiety, with nitrous oxide, a gas that provides quick sedation. This combination offers a flexible approach to managing anxiety and sedation in children, potentially improving comfort and cooperation during laceration repair.
2491011Eligibility Criteria
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.Inclusion Criteria
My cut is simple and doesn't need strong sedation for repair.
I am between 2 and 12 years old.
My wound was stitched by an emergency doctor or their trainee.
+2 more
Exclusion Criteria
Hypersensitivity to any intervention
Hemodynamic abnormalities: bradycardia or hypotension < 2 SD of age-related normal value
One of my nostrils is blocked, possibly affecting medication absorption.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Preparation and Treatment
Participants receive anxiolytic treatment (IN dexmedetomidine, IN midazolam, or N2O) for laceration repair
40 minutes
1 visit (in-person)
Recovery
Participants are monitored post-procedure for any immediate adverse effects and satisfaction is assessed
40 minutes
1 visit (in-person)
Follow-up
Participants are monitored for late maladaptive behaviors and any adverse effects up to 72 hours post-discharge
72 hours
Participant Groups
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.
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
Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
🇺🇸 Approved in United States as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
🇨🇦 Approved in Canada as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
🇯🇵 Approved in Japan as Precedex for:
- Sedation in intensive care settings
- Procedural sedation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
London Health Sciences CentreLondon, Canada
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Who Is Running the Clinical Trial?
London Health Sciences Centre OR Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
Lawson Health Research InstituteLead Sponsor
References
A Retrospective Evaluation of the Safety Profile of Dexmedetomidine and Nitrous Oxide for Pediatric Dental Sedation. [2021]Purpose: The purpose of this study was to compare the safety of three different sedation regimens for pediatric dental procedures to examine the safety of intranasal dexmedetomidine paired with nitrous oxide (N₂O). Methods: This was a retrospective chart review of 149 three-to six-year-old healthy patients who underwent sedation to complete dental treatment. Forty-nine patients received intranasal dexmedetomidine with nitrous oxide (DEXNO), 47 received oral midazolam with nitrous oxide (MIDNO), and 53 received oral midazolam and oral hydroxyzine with nitrous oxide (MIDHYXNO). Demographic data, procedural times, vital signs, and adverse events were recorded. Results: No patients in any of the three groups experienced major adverse events. All groups experienced some degree of hypotension. One of the 49 DEXNO cases experienced bradycardia intraoperatively. No cases required clinical intervention. Conclusion: This pilot study suggested that intranasal dexmedetomidine with nitrous oxide is a safe sedation regimen for pediatric procedures, comparable to combinations of oral midazolam with nitrous oxide and oral midazolam and oral hydroxyzine with nitrous oxide.
Double-blind Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department. [2018]The objective of this study was to compare anxiolysis with intranasal dexmedetomidine, an alpha-2 agonist, versus intranasal midazolam for pediatric laceration repairs.
Intranasal Midazolam Premedication for Anxiolysis in Children Reluctant to Receive Nitrous Oxide Sedation via Nasal Hood: An In Vivo Randomized Control Trial. [2022]The aim of the study was to compare administration of 0.1 mg/kg intranasal midazolam as premedication against a normal saline control in alleviating anxiety relating to and increasing acceptance of nasal hood by child patients receiving nitrous oxide sedation.
[Which sedation for minor trauma surgery in children?]. [2014]Children under 6 often show marked anxiety and physical pain during laceration repair. If locally infiltrated anesthetics usually give a good control of physical pain, they have no effect on anxiety and restlessness for which several medications are available for conscious sedation. Continuous nitrous oxide, intramuscular sedative "cocktail" with meperidine-promethazine-chlorpromazine or intravenous fentanyl have various inconveniences and therefore are not ideal for this purpose. By contrast, Midazolam, a short acting watersoluble benzodiazepine with anxiolitic, hypnotic and anterograde amnestic effect, appears to be a safe and effective treatment when given orally or intranasally for alleviating anxiety in under 6 year-old out-patient in emergency department; its rectal administration appears less effective and needs further studies before to be routinely used.
A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study. [2022]To evaluate and compare the efficacy and safety of Intranasal (IN) Dexmedetomidine, Midazolam and Ketamine in producing moderate sedation among uncooperative pediatric dental patients.
Efficacy of intranasal dexmedetomidine versus oral midazolam for paediatric premedication. [2020]Premedication is an integral component of paediatric anaesthesia which, when optimal, allows comfortable separation of the child from the parent for induction and conduct of anaesthesia. Midazolam has been accepted as a safe and effective oral premedicant. Dexmedetomidine is a selective alpha-2 agonist with sedative and analgesic effects, which is effective through the transmucosal route. We compared the efficacy and safety of standard premedication with oral midazolam versus intranasal dexmedetomidine as premedication in children undergoing elective lower abdominal surgery.
A comparison of the sedative effect of oral versus nasal midazolam combined with nitrous oxide in uncooperative children. [2022]To compare a combination of oral midazolam (0.2 mg/kg body weight) and nitrous oxide-oxygen sedation with a combination of intranasal midazolam (0.1 mg/kg body weight) and nitrous oxide-oxygen sedation for effectiveness, patient acceptability and safety profile in controlling the behaviour of uncooperative children.
Safety and physiologic effects of intranasal midazolam and nitrous oxide inhalation based sedation in children visiting Saveetha Dental College and Hospitals, India. [2023]A large number of patients avoid dental care due to anxiety. Various techniques are available for behaviour related management. Therefore, safety and physiologic effects of intranasal midazolam and nitrous oxide inhalation based sedation in children aged 4 to 8 years visiting Saveetha Dental College and Hospitals, India is of interest. 35 anxious patients aged 4 to 8 years were included in the study. The patient received either intranasal midazolam/nitrous oxide in the first visit and vice versa at the second visit. The onset of sedation, recovery time and procedure duration were recorded using a timer. Physiological parameters were recorded using a monitor. Safety scale was used for assessing prevalence of adverse reactions. There was no significant difference between the groups in safety scale scores, recovery time and procedure duration. Midazolam group showed a statistically significant faster onset of sedation and a statistically significant increase in heart rate at four recorded time-points. All the vitals were within the physiological limits. Thus, intranasal midazolamis a safe alternative to nitrous-oxide sedation in completing the intended dental treatment while managing the anxious children in dental clinic.
The effect of oral midazolam on anxiety of preschool children during laceration repair. [2019]Preschool age children often experience marked anxiety and physical pain during laceration repair. Locally infiltrated anesthetics or topical tetracaine, adrenaline, and cocaine (TAC) usually control the physical pain but have little or no effect on anxiety. Midazolam is a short-acting benzodiazepine with anxiolytic, hypnotic, and antegrade amnestic effects. In a double-blind, randomized clinical trial, we evaluated the efficacy of midazolam in alleviating anxiety during laceration repair in children less than 6 years old. On admission to the emergency department, anxiety level was determined on a scale of 1 to 4 based on a predetermined behavior criteria. Patients with high anxiety level (3 or 4) received a single oral dose of either midazolam (0.2 mg/kg) or placebo. The anxiolytic effect of midazolam was considered adequate if the anxiety level decreased two or more points (from 4 to less than or equal to 2 or from 3 to 1) during laceration repair. In the midazolam group (30), 70% of the children had a two-point or more decrease in anxiety level compared with 12% in the placebo group (25) (P less than .0001). No respiratory depression or other complications were noted in the midazolam group. We conclude that a single oral dose of midazolam (0.2 mg/kg) is a safe and effective treatment for alleviating anxiety in children less than 6 years old during laceration repair in the ED.
A randomized clinical trial of continuous-flow nitrous oxide and midazolam for sedation of young children during laceration repair. [2022]To compare the efficacy and complication profile of oral midazolam therapy and continuous-flow 50% nitrous oxide in alleviating anxiety during laceration repair in children 2 to 6 years old.
Intranasal midazolam as a sedative for children during laceration repair. [2022]We performed a retrospective chart review to determine the onset, duration, safety, and clinical sedative effects of 0.2 to 0.5 mg/kg intranasal midazolam in young children during laceration repair. Of 408 children treated for lacerations during an 8-month period, 42 (10%) received intranasal midazolam. Documentation was adequate for detailed analysis in 40 cases. Data are reported as mean +/- standard deviation and the frequency with 95% confidence limit (CL) estimates. The mean age of the study population was 32 +/- 9 months (range 12 months to 6 years), and the mean body mass was 14.5 +/- 3 kg. Topical or injected local anesthesia was used in 37 cases. Overall, 73% (CL 56% to 85%) of the children achieved adequate sedation. However, those receiving 0.2 to 0.29 mg/kg had adequate sedation in only 27% (CL 6% to 60%) of the cases compared with 80% (CL 52% to 95%) and 100% (CL 79% to 100%) when 0.3 to 0.39 and 0.4 to 0.5 mg/kg respectively were administered. When achieved, sedation occurred within 12 +/- 4 minutes, recovery occurred at 41 +/- 9 minutes, and discharge occurred at 56 +/- 11 minutes. No vomiting or clinically significant oxygen desaturation (defined as a drop of > 4% or to