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NCT01669642 · ClinicalTrials.gov registry record · NA
Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 111
- Enrollment target
NCT01669642 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 111 participants.
The verdict
NCT01669642, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 111 participants
- Enrollment target
Study Summary
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,
Interventions
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01669642
The ClinicalTrials.gov registry entry for NCT01669642 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketamine is the first listed.
NCT01669642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01669642 about?
NCT01669642 is a clinical study titled "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 be...
What is the current status of trial NCT01669642?
This trial is currently completed. It is a NA study. The enrollment target is 111 participants. The study started on 2012-04. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01669642?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT01669642?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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