Clinical trial · Interventional
Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients
Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial
NCT03043430CI-TRIAL-00065946terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Research manpower shortage
Summary
Brief summary (as posted)
Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric patients requiring minor procedures in the Emergency Department setting. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale Preoperative Anxiety Scale (mYPAS).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Procedural Anxiety | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine 100 MG/ML | Drug | — | UNRESOLVED |
| Midazolam 5 MG/ML | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ketamine
- description
- Ketamine 100 mg/mL concentration administered in a single 1.0 mg/kg dose with a maximum of 50mg intranasal via mucosal atomization device.
- interventionNames
- Drug: Ketamine 100 MG/ML
- type
- ACTIVE_COMPARATOR
- label
- Midazolam
- description
- Midazolam 5 mg/mL concentration administered in a single administered in a single 0.3 mg/kg dose with a maximum of 5mg intranasal via mucosal atomization device.
- interventionNames
- Drug: Midazolam 5 MG/ML
Primary outcomes (1)
- measure
- Change in mYPAS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age 2 to 12 years who present to the ED * Requiring intravenous access * Requiring laceration repairs * Requiring incision and drainage of abscesses * Requiring digital nerve blocks * Requiring radiological imaging * Requiring bladder catheterization * Requiring foreign body removal. Exclusion Criteria: * Vital sign abnormalities greater than 20% deviation from age-normalized ranges * Altered mental status/delirium or intoxication * Patient or patient's parent/guardian are unwilling to participate or provide informed consent * Any allergy to ketamine or midazolam * Patient is female with history of menarche * Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis * Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias * Presence of intracranial mass or vascular lesion. * Presence of a history of psychosis or hallucinations * Weight greater than 100kg * History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months * Non-English speaking/reading parent/guardian and/or patients * Patient is acutely psychotic * Provider feels that patient currently or likely will require chemical and/or physical restraints * History of prolonged QT-interval * Nasal trauma * Epistaxis
References
Publications (4)
- BACKGROUNDHosseini Jahromi SA, Hosseini Valami SM, Adeli N, Yazdi Z. Comparison of the effects of intranasal midazolam versus different doses of intranasal ketamine on reducing preoperative pediatric anxiety: a prospective randomized clinical trial. J Anesth. 2012 Dec;26(6):878-82. doi: 10.1007/s00540-012-1422-6. Epub 2012 Jun 12. PMID 22688444
- BACKGROUNDRoelofse JA, Shipton EA, de la Harpe CJ, Blignaut RJ. Intranasal sufentanil/midazolam versus ketamine/midazolam for analgesia/sedation in the pediatric population prior to undergoing multiple dental extractions under general anesthesia: a prospective, double-blind, randomized comparison. Anesth Prog. 2004;51(4):114-21. PMID 15675259
- BACKGROUNDNarendra PL, Naphade RW, Nallamilli S, Mohd S. A comparison of intranasal ketamine and intranasal midazolam for pediatric premedication. Anesth Essays Res. 2015 May-Aug;9(2):213-8. doi: 10.4103/0259-1162.154051. PMID 26417129
- BACKGROUNDKhatavkar SS, Bakhshi RG. Comparison of nasal Midazolam with Ketamine versus nasal Midazolam as a premedication in children. Saudi J Anaesth. 2014 Jan;8(1):17-21. doi: 10.4103/1658-354X.125904. PMID 24665234