Anxiety Clinical Trial
Official title:
Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial
NCT number | NCT03043430 |
Other study ID # | C.2016.021 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | April 2023 |
Verified date | April 2023 |
Source | Brooke Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 10 |
Est. completion date | April 2023 |
Est. primary completion date | April 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | San Antonio Military Medical Center | Fort Sam Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center |
United States,
Hosseini 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. — View Citation
Khatavkar 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. — View Citation
Narendra 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. — View Citation
Roelofse 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mYPAS | Modified Yale preoperative anxiety scale | Change in score between initial measurement versus 5 minutes pre-procedure | |
Secondary | Change in sedation scale | University of Michigan sedation scale | Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge | |
Secondary | Change in pain rating (Wong-Baker Pain Faces Rating Scale) | Wong-Baker Pain Faces Rating Scale | Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge | |
Secondary | Change in anxiety score (Visual analogue scale) | Visual analogue scale | Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge |
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