Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nasal Ketamine for Minor Procedures in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02839928
Recruitment Status : Unknown
Verified July 2016 by Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Kaplan Medical Center

Brief Summary:
Nasal Ketamine has previously been tested in children for deep sedation or preoperative anxiolysis. The investigators intend to test the efficacy of low dose nasal Ketamine in children undergoing minor procedures in the emergency department.

Condition or disease Intervention/treatment Phase
Pain Drug: Intranasal ketamine Device: Intranasal atomizer Drug: EMLA Not Applicable

Detailed Description:

The investigators propose a feasibility study of intranasal ketamine to provide analgesia and anxiolysis before minor procedures. This will be a single-blinded randomized study of inhaled ketamine in a convenience sample of children ages 4-12 years of age undergoing minor procedures. For the purpose of this study, the investigators will limit minor procedures to venipuncture and IV placement, and will further limit the patient population to children who are deemed by the investigators to show resistance to IV placement or venipuncture without premedication. The investigators have chosen the ages 4-12 years because these children are verbal and able to rate their pain on the VAS scales, because they are likely to require restraint and to require a staff member to assist parents with restraint, and because the Green study found this age range to have the fewest adverse events with ketamine.

The investigators propose a uniform dosing of 50 mg/ml intranasal ketamine at 1 mg/kg. Ketamine will be diluted to achieve volumes between 0.5-1 ml distributed between nares. The plasma concentration of intranasal ketamine is just over a fifth of IV ketamine, and the peak serum concentration is reached an average of fifteen minutes later than IV ketamine. Thus, intranasal administration found to have achieved mild sedation at 1 mg/kg would be expected to achieve a lower level of sedation than a 0.2 mg/kg slow IV administration, which is compatible with subdissociative dosing used for analgesia. A 1 mg/kg intranasal dose is also consistent with the lower end of the dosing spectrum used in the anesthesia literature for preoperative sedation.

The investigators propose a pilot study of 20 children ages 4-12 years undergoing venipuncture or IV insertion. After obtaining informed consent from a single parent (the investigators request exclusion from requiring consent from both parents), the children will be assigned to receive 1 mg/kg intranasal ketamine via atomizer. Consent will occur after the treating physician has decided that the child requires bloodwork or IV placement, and will not impact this decision.

All children will receive EMLA. EMLA cream is the standard of care in our area and we feel that it would not be ethical to withhold EMLA for the purpose of the study. Ketamine will add to the incomplete analgesia of EMLA, and may be a better option than EMLA in children who are known to have difficult venous access. EMLA is not universally effective -- having been found to decrease VAS pain scores by only 61%-- and causes vasoconstriction, which can increase the procedural fail rate.

Ketamine will be administered 30 minutes after EMLA is applied. At or about the 45 minute mark, the procedure will be attempted.

All children will receive continuous monitoring of pulse oximetry, blood pressure and pulse rate from the time medication is administered until the child is discharged from the emergency department. All children will be under the direct and continuous observation of ED staff. The procedure will be completed within twenty minutes of the completion of the nasal administration.

After the procedure is completed, children will be asked to rate the level of procedural pain on the Faces scale. A parent and the nurse at the procedure will rate the estimated procedural pain on the VAS scale. Child, parent as nurse will be blinded to each other's score.

The investigators intend to show that nasal ketamine requires a minimal disruption in ED resources and treatment time, effectively treats pain and increases the child's compliance with venipuncture and IV placement, increases parent satisfaction, and is without serious adverse events.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal Ketamine: Mild Sedation and Analgesia for Minor Procedures in the Pediatric Emergency Department (ED)
Study Start Date : July 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Treatment
The experimental arm consists of children given intranasal Ketamine 1 mg/kg, once
Drug: Intranasal ketamine
The experimental arm consists of an single intranasal administration of Ketamine (Ketalar).
Other Name: Ketalar

Device: Intranasal atomizer
Ketamine will be applied to each nare via intranasal atomizer
Other Name: LMA MAD intranasal atomizer

Drug: EMLA
Other Name: EMLA cream, a topical analgesic, will be applied prior to the procedure




Primary Outcome Measures :
  1. Pain score (VAS) [ Time Frame: Up to 24 weeks ]
    The investigators will record the visual analog scale pain score as reported by patients and caregivers both before and after the administration of intranasal ketamine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children age 4-12 years old presenting to the pediatric ED
  • Children determined by the treating physician to require either venipuncture or IV placement
  • Children determined by the treating physician to show resistance to the procedure without pre-medication

Exclusion Criteria

  • ASA 3 or higher
  • Weight below 15 kg or above 50 kg
  • Hypoxia below 95% on presentation or noted to be tachypneic for age or dyspneic.
  • Judged by staff to need an urgent procedure that cannot be delayed (i.e. Nursing triage levels 1-2)
  • An existing source of pain that results in a VAS greater than 3 at triage (i.e. Headache, fracture)
  • More than four prior ED visits in the last four months
  • Developmentally delayed and unable to reliably rate pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839928


Contacts
Layout table for location contacts
Contact: Eric Scheier 4103586230 eric.scheier@gmail.com
Contact: Eric Scheier 011972527276804 eric.scheier@gmail.com

Sponsors and Collaborators
Kaplan Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Eric Scheier, MD Physician, pediatric emergency department

Layout table for additonal information
Responsible Party: Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT02839928     History of Changes
Other Study ID Numbers: 0034-16-KMC
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action