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Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children

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ClinicalTrials.gov Identifier: NCT02519595
Recruitment Status : Completed
First Posted : August 11, 2015
Results First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Nirupama Kannikeswaran, Children's Hospital of Michigan

Brief Summary:
There is a wide variation of published IV ketamine dosing regimens used for procedural sedation in children in the Emergency Department (ED). The purpose of the study was to compare the efficacy, duration of sedation and adverse events between the three commonly administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional administration method of 30-60 second infusion for ED sedation in children.

Condition or disease Intervention/treatment Phase
Moderate, Deep Sedation Drug: Ketamine IV 1mg/kg Drug: Ketamine IV 1.5mg/kg Drug: Ketamine IV 2mg/kg Phase 4

Detailed Description:
This was a prospective, double-blind, randomized controlled trial of children aged 3 to 18 years who received IV ketamine for procedural sedation and analgesia (PSA) for orthopedic procedures, incision and drainage (I & D) of skin abscess and laceration repair in an inner city, tertiary care pediatric ED. Random sequence allocation was performed using a computer-generated, random number table by the study research pharmacist. The study participants were grouped according to their age as follows (1) 3-6 years (2) 7-12 years (3) 13-18 years. Children from each age group were assigned in equal numbers to all three ketamine dosing (1 mg/kg, 1.5 mg/kg and 2 mg/kg) groups using random permuted blocks stratified by the pharmacist. All ED staff including the physician and the nurse in charge of sedation, the study research assistant, the parents/guardians and the study subjects were blinded to the randomization and the group assignments. The dosage and administration of additional doses of ketamine were left to the discretion of the ED physician in charge of the sedation. The research team did not participate in the clinical care including sedation of the patient. Children were monitored per ED policy for the entire duration of sedation. Three 1 ml blood samples for the ketamine assay was collected from the existing intravenous access at three time intervals: 3-5 minutes after ketamine administration, at midpoint during the procedure and prior to discharge of the patient from the ED. In the event a second dose of ketamine was administered, a 4th 1 ml sample was collected 3-5 minutes after the 2nd dose in children weighing >20 kilograms. Patient demographics, procedure type, NPO status , ASA classification, pain medication administered prior to sedation (timing, dosage and type), number and total doses of ketamine administered after the initial study dose, sedation efficacy and duration, length of procedure, adverse events related to sedation, interventions performed to address the adverse events and patient disposition were collected. The study research assistant also performed a follow up phone call to the parents/caregivers of the children 48 hours after ED discharge to collect information on adverse events that happened at home . A total of 3 attempts were made to contact the parent/caregiver after which the participant was considered as lost to followup.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
Study Start Date : August 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: ketamine IV 1 mg/kg
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients
Drug: Ketamine IV 1mg/kg
Intervention: Ketamine IV 1mg/kg

Experimental: Ketamine IV 1.5 mg/kg
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients
Drug: Ketamine IV 1.5mg/kg
Intervention: Ketamine IV 1.5 mg/kg

Experimental: Ketamine IV 2 mg/kg
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients
Drug: Ketamine IV 2mg/kg
Intervention: Ketamine IV 2 mg/kg




Primary Outcome Measures :
  1. Sedation Efficacy [ Time Frame: Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours ]
    Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.

  2. Pain [ Time Frame: Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes ]
    Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4).


Secondary Outcome Measures :
  1. Sedation Duration [ Time Frame: Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours ]
    Length of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring >9) followed at our institution.

  2. Additional Dose [ Time Frame: Patients will be assessed during procedure . Approximately 1 hours ]
    Number of participants to whom additional doses of ketamine administered apart from the study dose

  3. Adverse Events [ Time Frame: Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days., ]
    Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them

  4. Sedation Satisfaction [ Time Frame: At the end of the procedure. Approximately 1 hour ]
    Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 3 -18 years of age
  • Belonging to American Society of Anesthesiologists (ASA) classification 1 or 2
  • Receiving IV ketamine for procedural sedation for orthopedic procedures,
  • Incision and Drainage of skin abscess and laceration repair

Exclusion Criteria:

  • Contraindications to use of Ketamine
  • Parents or legal guardian not available or declined to provide informed consent
  • Child declined to provide assent,
  • Patients that received intramuscular ketamine,
  • Patient that received benzodiazepines in addition to ketamine
  • Children weighing >100 kilogram
  • Children with developmental disabilities.
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Responsible Party: Nirupama Kannikeswaran, Associate Professor of Pediatrics and Emergency Medicine, Children's Hospital of Michigan
ClinicalTrials.gov Identifier: NCT02519595    
Other Study ID Numbers: R1-2013-88
First Posted: August 11, 2015    Key Record Dates
Results First Posted: October 12, 2016
Last Update Posted: October 12, 2016
Last Verified: August 2016
Keywords provided by Nirupama Kannikeswaran, Children's Hospital of Michigan:
Procedural sedation
ketamine
children
Additional relevant MeSH terms:
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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