Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01669642
First received: August 8, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The purpose of the study is to find the dose of rapidly administered ketamine in 3 different pediatric age groups (2-5, 6-11 and 12-17) for abscess drainage and fracture reduction.

Ketamine is the most common drug administered to children to facilitate painful procedures in the emergency setting because it achieves potent sedation, pain relief and amnesia with minimal adverse cardiopulmonary effects.(1-5) However, the 1-2 hour recovery period (1,6) associated with standard ketamine administration guidelines(7) strains work flow because it requires bedside one-on-one nurse monitoring in a treatment room, tying up these limited and valuable resources. Consequently, a combination of two other drugs, propofol + fentanyl (P/F), with recovery of 20-30 minutes, is rapidly gaining popularity for procedural sedation despite more frequent respiratory depression, apnea and hypotension caused by this technique.(2,4,8,9)

The investigators believe recovery associated with our novel method for administering ketamine is significantly shorter than with the standard larger dose more slowly administered ketamine technique(7). Through the investigators clinical experience, the investigators have found rapid infusion of smaller than standard doses of ketamine safely achieves the drug's sedative effect, with the benefit of more rapid recovery due to the use of a smaller dose. However, this novel technique challenges published beliefs that time of recovery from ketamine sedation does not differ significantly with the dose administered, within the usual dose ranges, and that rapid infusion may cause respiratory depression, similar to that seen with other classes of sedative-analgesic drugs.(7,10) the investigators believe the slow infusion recommended by standard guidelines(7) requires a larger ketamine dose necessary to achieve effective sedation, and, consequently, prolongs recovery. It is the prolonged recovery that has prompted increased use of other less safe but briefer sedatives, such as propofol/fentanyl. By demonstrating patients recover rapidly with new ketamine technique, without increased adverse cardiopulmonary effects, the investigators will provide clinicians with an important new method for ketamine procedural sedation. The investigators believe clinicians will prefer more rapid recovery ketamine technique because it is safer and reduces pain and distress better than the propofol/fentanyl combination for sedation.

The investigators complete proposal requires two steps. In Step One, this proposal, the investigators will determine the minimum effective dose of rapidly infused ketamine that achieves deep sedation for at least 5 minutes in 95% of children (ED95). Two groups of patients will be studied: one group is patients undergoing abscess incision and drainage and the other group is patients undergoing fracture reduction in our Emergency Department. The investigators believe that the ED95 is different for both the groups as the severity of pain is different. The investigators will compare the safety and recovery times to published standard ketamine techniques. In the following study, Step Two, the investigators will compare this novel technique, in a blinded randomized trial using the ED95 ketamine dose determined in Step One to the standard ketamine technique to determine if the novel technique results in significantly shorter recovery without an increase in the frequency of adverse effects. The study the investigators are proposing in this submission is Step One only.


Condition Intervention
Abscess
Fracture
Drug: Ketamine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mean Effective Dose of Rapidly Administered Ketamine for Brief Pediatric Procedural Sedation

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • to find the mean effective dose (ED95)of ketamine [ Time Frame: when results are analyzed; in approximately 15 months ] [ Designated as safety issue: No ]
    this is the dose of ketamine that can provide effective sedation in 95% of children(ED95) undergoing abscess drainage or fracture reduction. ED95 will be calculated for the 3 age groups (2-5, 6-11 and 12-17) independently for both the procedures: abscess drainage and fracture reduction.


Secondary Outcome Measures:
  • adverse effects during procedural sedation and after discharge [ Time Frame: noted throughout the study; in approximately 15 months ] [ Designated as safety issue: Yes ]
    we will document if any of the participant experienced any adverse events during procedural sedation. we will also do a telephone follow up one week after discharge to document any adverse events after discharge.


Other Outcome Measures:
  • recovery time to sedation score 4 [ Time Frame: documented during procedural sedation; in approximately 15 months ] [ Designated as safety issue: No ]
    we will document the time it took for recovering of the sedation score to 4 (from a score of 2 or less) which is "Drowsy, eyes open or closed, but easily arouses to consciousness with verbal stimulus"

  • recovery to aldrete score of 10 [ Time Frame: documented during procedural sedation; in approximately 15 months ] [ Designated as safety issue: No ]
    during recovery, all participants are monitored for recovery to baseline at which point participants are ready for discharge. we will document the time from induction to recovery to aldrete score of 10.


Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
participants who get the ketamine sedation will be enrolled. there is no control or comparison group.
Drug: Ketamine
participants who need ketamine sedation for abscess drainage or fracture reduction will be approached for enrollment. there is no comparison group. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
Other Name: Ketalar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Healthy children (ASA Physical Status I and II) 2-17 yrs old who require deep sedation for abscess incision and drainage in the St. Louis Children's Hospital Emergency Unit

Exclusion Criteria:

  1. Fever (temperature ≥ 38 0Celcius) due to upper respiratory infection.
  2. Obesity (BMI > 2SD for age and sex) or undernourishment (BMI < 2SD for age and sex)
  3. Children with psychosis/psychiatric diagnosis (currently under the care of psychiatrist and/or taking psychiatric medication. ADHD is not an exclusion criterion)
  4. Previous adverse reactions with ketamine sedation
  5. Receipt of opioid analgesic in the ED (oxycodone/morphine etc) prior to sedation
  6. Multiple abscesses (2 or more) requiring I & D
  7. Non -English speaking families
  8. Children under foster care.
  9. Previous participation in current research study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669642

Locations
United States, Missouri
St Louis Children's hospital, Washington university Recruiting
St Louis, Missouri, United States, 63123
Contact: SRI CHINTA, MD    314-454-2341    CHINTA_S@KIDS.WUSTL.EDU   
Contact: ROBERT Kennedy, MD    314 454 2341    KENNEDY@KIDS.WUSTL.EDU   
Principal Investigator: SRI S CHINTA, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: sri s chinta, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01669642     History of Changes
Other Study ID Numbers: 201112017
Study First Received: August 8, 2012
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
ketamine sedation
pediatric
abscess drainage
fracture reduction

Additional relevant MeSH terms:
Abscess
Fractures, Bone
Suppuration
Infection
Inflammation
Pathologic Processes
Wounds and Injuries
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014