A Phase 4 interventional study of Intranasal Midazolam and Intranasal Dexmedetomidine in Laceration of Skin, Anxiety and Discharge Time, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to participants aged 1 Year to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by University of Oklahoma · Phase 4, Interventional, and Supportive care
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Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study that will compare three intranasal medications (Intranasal Midazolam, Dexmedetomidine, and Ketamine) to evaluate the length of stay after medication administration along with patient and provider satisfaction. The objective of this study is to demonstrate superior intranasal anxiolysis for pediatric laceration repairs with the shortest emergency department stay and highest patient and provider satisfaction. Based on previous studies and medication pharmacokinetics, we hypothesize that Intranasal Ketamine will have the shortest Emergency Department (ED) stay followed by Midazolam and then Dexmedetomidine with the longest stay; however, Dexmedetomidine will have the highest patient and provider satisfaction followed by Ketamine and then Midazolam.
Children commonly present to ED with injuries requiring procedures that can be painful or require a child to be absolutely still. Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Multiple surveys of parents and families have showed that ED satisfaction is highly dependent on the degree of pain a patient experiences and the efforts made to alleviate the pain. Therefore, improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion.
Intranasal Midazolam is widely used for minimal procedural anxiolysis in pediatric population. Intranasal medication delivery has the highest parent and provider satisfaction with the advantage of avoiding painful needle stick and faster absorption compared to oral or intramuscular medication. Midazolam is a gamma-aminobutyric acid (GABA) receptor agonist that can provide anxiolysis and amnesia but no analgesia. Intranasal Midazolam has a rapid onset of 5-10 minutes with peak at 30 minutes. There have been limited studies evaluating the length of stay or time to discharge after medication administration with an average length of stay of about 30 minutes. It has been shown to be safe and effective in children for minor procedures; however, intranasal Midazolam is notoriously noxious and irritating to nasal mucosa and requires larger volumes for intranasal dosing. Main side effects include respiratory depression and hypotension. It is also known to cause paradoxical reaction with hyperactivity, agitation, and restlessness especially in developmentally delayed or children with Autism or behavioral concerns. Therefore, several new studies have evaluated other newer intranasal medications for minor procedures including intranasal Dexmedetomidine and intranasal Ketamine.
Dexmedetomidine is an alpha 2 agonist that mirrors sleep in children and can provide anxiolysis and minimal analgesia. Intranasal dosages that have provided adequate minimal sedation is 2-4mcg/kg (max dosage 100-200mcg) with wide range of onset 10-45 mins with average 30 minutes and peak at 90 minutes. Unlike Midazolam, it preserves airway reflexes without clinically significant hemodynamic instability in children. Studies have also shown that it is well tolerated by children and preferred in children with Autism and behavioral concerns.
Ketamine is an N-methyl-D-aspartate (NMDA) antagonist that provides both anxiolysis and analgesia. It is widely used in ED settings for intravenous procedural sedation; however, intranasal route provides non-invasive method of medication administration. Gutherie et al conducted a study demonstrating intranasal Ketamine providing safe and successful anxiolysis and analgesia in pediatric patients in an ED setting. Intranasal dosage of 3-5mg/kg (max dosage 100-200mg) provides optimal onset of action within 10 minutes with peak at 15-20 minutes and duration of 45-60 minutes. It has few significant side effects including the rare laryngospasm and recovery agitation, however, it preserves airway reflexes and favorable in hemodynamic instability.
Previous Studies:
Limited studies have demonstrated anxiolysis with patient and provider satisfaction or time to discharge after medication administration comparing intranasal Midazolam to intranasal Dexmedetomidine or intranasal Ketamine in a pediatric emergency medicine setting. Neville et al conducted a study comparing intranasal Dexmedetomidine and intranasal Midazolam prior to laceration repair in a pediatric emergency department and concluded that patients who received Dexmedetomidine had less anxiety at the time of positioning for the procedure. Several other studies have demonstrated similar outcomes with better patient and provider satisfaction in pre-operative settings, imaging, and dental settings. Surendar et al is the only study that compared all three intranasal medications. The study included uncooperative pediatric patients in a dental setting. Although overall differences were not statistically significant, the onset of sedation was rapid among Intranasal Ketamine and Midazolam groups but overall success was highest in Dexmedetomidine group.
Objective/Aims/Hypothesis:
This is the first study that will compare all three intranasal medications to evaluate the length of stay after medication administration along with patient and provider satisfaction. The objective of this study is to demonstrate superior intranasal anxiolysis for pediatric laceration repairs with the shortest emergency department stay and highest patient and provider satisfaction. The primary outcome will measure the time to discharge after medication administration. Other measurements with include patient's anxiety using previously validated scale Modified Yale Preoperative Anxiety Scale (mYPAS) and physician and parent satisfaction using 5 point Likert scale. Based on previous studies and medication pharmacokinetics, we hypothesize that Ketamine will have the shortest ED stay followed by Midazolam and then Dexmedetomidine with the longest stay; however, Dexmedetomidine will have the highest patient and provider satisfaction followed by Ketamine and then Midazolam.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Exclusion Criteria:
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose/Concentration: 5mg/ml of 0.4mg/kg Midazolam (max dose 10mg). Adverse side effects include respiratory depression and hypotension. Intranasal Midazolam is standard of care for minimal procedures in pediatric ED.
Drug: Intranasal Midazolam
Dose/Concentration: 100mcg/ml of 2mcg/kg Dexmedetomidine (max dose 100mcg). Adverse side effects include Hypotension and Bradycardia at high dosages. IV Dexmedetomidine is FDA approved and widely used in sedation. IN form isn't FDA approved; however, it has been approved to conduct research studies that have showed its efficacy in pre-operative settings, imaging-CT or MRI, dental procedures, and much more. Specifically, in a pediatric ED setting, Neville et al conducted a study comparing intranasal Dexmedetomidine and intranasal Midazolam prior to laceration repair in a pediatric emergency department and showed safe administration of Dexmedetomidine.
Drug: Intranasal Dexmedetomidine
Dose/Concentration: 100mg/ml of 3mg/kg Ketamine (max dose 100mg). Adverse side effect include Laryngospasm. IV Ketamine is FDA approved and widely used in procedural sedation in pediatric EDs. IN form isn't FDA approved in pediatric population; however, it has also been approved to conduct research studies especially in combination with other medications. Gutherie et al conducted a study demonstrating intranasal Ketamine providing safe and successful anxiolysis in pediatric patients in an ED setting.
Drug: Intranasal Ketamine
Using a computer-generated randomization schedule by the research pharmacist, all 90 subjects will be divided into 3 even groups to receive either medication A (intranasal Midazolam), B (intranasal Dexmedetomidine), or C (intranasal Ketamine). Based on the randomization schedule, the pharmacist will dispense medication A, B, or C to the chronological number provided in the order. The total amount of the medication will be based on the patient's charted weight. Small volumes of less than 1ml per nostril are preferred for reliable absorption; therefore, the medication will be dispensed in a 1ml syringe and the barrel of the syringe will be covered by the pharmacist. All the syringes sent from the pharmacy will appear the same, regardless of the volume of the medication.
Also known as: Intranasal Versed
See above
Also known as: Intranasal Precedex
See above
The primary outcome will measure the time to discharge after intranasal medication administration
The nurse will document the time the medication is administered and the time of discharge once the patient meets American Academy of Pediatrics (AAP) criteria of discharge. AAP discharge criteria includes cardiovascular function and airway potency satisfactory; arousable and protective reflexes are intact; able to talk appropriately for age; able to sit up appropriately for age; and state of hydration is adequate
Time frame: Day 1
The secondary outcome will measure patient's anxiety using the previously validated scale mYPAS and physician and parent satisfaction using a 5-point Likert scale
Once the pharmacy dispenses the medication, the nurse will fill out an 18-point scale survey (Modified Yale Preoperative Anxiety Scale \[mYAS\]) to assess the patient's anxiety level. At the end of the procedure, both the physician and the parent will answer a question using a 5-point Likert scale and the nurse will fill out the same mYAS survey utilized prior to medication administration. The mYAS scale evaluates four domains including activity, vocalizations, emotional expressivity, and state of apparent arousal. The scoring is combined into a total anxiety score between 23.3 and 100 with a patient scoring less than or equal to 30 being categorized as not anxious. The scores on 5-point Likert scale are categorized into very satisfied, satisfied, no difference, unsatisfied, very unsatisfied for 5, 4, 3, 2, and 1, respectively.
Time frame: Day 1
Plan to share: Yes — Research records for this study will be maintained for three years following its completion to allow for inspection by government agencies, the sponsor, the University, and other applicable entities.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Three years after the completion of the study
Started Nov 2023 (actual). Primary completion is estimated for May 2025, 18 months after the start.
Of 52 non-industry phase 4 interventional studies under Anxiety Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 18 months is below that.
Counting every sponsor, half of 59 studies reached it within 27 months; a quarter within 16 and three quarters within 47.
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Studies of the drugs tested here: Midazolam · Dexmedetomidine · Intranasal Ketamine