Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
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, 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.