Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children
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.
|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|
- 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.
- 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.
- 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.
|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)|
participants who get the ketamine sedation will be enrolled. there is no control or comparison group.
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01669642
|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|
|Principal Investigator:||sri s chinta, MD||Washington University School of Medicine|