Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children
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|ClinicalTrials.gov Identifier: NCT01669642|
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : March 12, 2018
Last Update Posted : April 25, 2019
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 or disease||Intervention/treatment||Phase|
|Abscess Fracture||Drug: Ketamine||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mean Effective Dose of Rapidly Administered Ketamine for Brief Pediatric Procedural Sedation|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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
- Median Effective Dose (ED50) and ED95 of Rapidly Administered Ketamine [ Time Frame: Dose administration through 5 minutes ]ED50 is the dose of rapidly administered ketamine that achieves effective sedation in 50% of patients. ED95 is the dose of ketamine that can provide effective sedation in 95% of children 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.
- ED95 [ Time Frame: Dose administration through 5 minutes ]ED95 is the dose of ketamine effective for 95% of children. this outcome is estimated from ED50.
- Vomiting [ Time Frame: Administration of ketamine through 2 week follow up call ]patients who experienced vomiting while in the ED or after discharge
- Number of Participants With Wisconsin Sedation Scale Score of 2 or Less at 1 Minute After First Dose of Ketamine [ Time Frame: Dose administration through 1 minute ]
This is a measure of sedation effectiveness; to assess the effectiveness of first dose of ketamine administered.
Possible values for the scale range from 0 to 6. A sedation score of 2 or less is considered adequate sedation. Values more than 2 indicate state of inadequate sedation. higher values indicate the need for additional doses of sedation.
Patients who achieved a score of 2 or less are considered effective sedation and a score of >2 are considered ineffective sedations.
- Total Sedation Time [ Time Frame: Time of administration of ketamine through sedation recovery ]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.
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): NCT01669642
|United States, Missouri|
|St Louis Children's hospital, Washington university|
|Saint Louis, Missouri, United States, 63123|
|Principal Investigator:||sri s chinta, MD||Washington University School of Medicine|