Procedural Sedation and Analgesia Clinical Trial
Official title:
Prospective Observational Evaluation of a New Protocol for Adult Procedural Sedation With Ketamine-propofol in a 1 on 4 Ratio at the Emergency Department of a Tertiary Hospital
Procedural sedation is the monitored use of sedatives and/or analgesics in a patient who must
endure a short painful or frightening procedure, bringing the patient into a sedative state
while retaining his spontaneous breathing and respiratory reflexes. Examples of these
procedures are cardioversion, repositioning of a shoulder luxation or incision of a skin
abscess, and these are frequently performed at the emergency ward. An easy and unambiguous
protocol for procedural sedation was composed at the emergency department of the University
Hospital of Ghent applicable for nearly all patients and procedures. This protocol included
recommendations for necessary monitoring such as continuous electrocardiogram, intermittent
blood pressure measurements, oxygen saturation and capnography, as well as safety precautions
for standby medications or medical devices for hemodynamic and airway control. As sedative
drug a mixture of ketamine and propofol ("ketofol") in a 1 on 4 ratio was selected based on
the available literature. Both ketamine and propofol are known to neutralise each other's
undesirable effects and ketamine adds an analgesic quality. Ketofol has proven effective and
safe in studies and is non-inferior to propofol. Though it is most often used in a 1 on 1
ratio, both pharmacological and clinical studies favour a 1 on 4 ratio.
An adult patient presenting at the investigating hospital in need of procedural sedation, who
agreed the informed consent for procedural sedation was treated according to this protocol.
Patients with an American Society of Anesthesiologist physical status classification system
status of III or more, with an anticipated difficult airway or intoxicated patients were
discussed with the anaesthesiology department to decide the feasibility of sedation in the
emergency ward setting. Pregnant patients were excluded.
Associated to this newly implemented protocol, an observational prospective study was
associated to verify the safety and effectivity, and to score the physicians satisfaction. A
separate informed consent was obtained for participation in the study to permit inclusion of
patient and procedural data into a registry. Data was registered by the physician responsible
for the sedation in a questionnaire. The investigators hypothesized the protocol with ketofol
in a 1 on 4 ratio would be safe and effective and would serve to facilitate procedural
sedation by emergency physicians.
Procedural sedation is the monitored use of sedatives and/or analgesics in a patient who must
endure a short painful or frightening procedure, bringing the patient into a sedative state
while retaining his spontaneous breathing and respiratory reflexes. Examples of these
procedures are cardioversion, repositioning of a shoulder luxation or incision of a skin
abscess, and these are frequently performed at the emergency ward. An easy and unambiguous
protocol for procedural sedation was composed at the emergency department of the University
Hospital of Ghent applicable for nearly all patients and procedures. This protocol included
recommendations for necessary monitoring such as continuous electrocardiogram, intermittent
blood pressure measurements, oxygen saturation and capnography, as well as safety precautions
for standby medications or medical devices for hemodynamic and airway control. As sedative
drug a mixture of ketamine and propofol ("ketofol") in a 1 on 4 ratio was selected based on
the available literature. Both ketamine and propofol are known to neutralise each other's
undesirable effects and ketamine adds an analgesic quality. Ketofol has proven effective and
safe in studies and is non-inferior to propofol. Though it is most often used in a 1 on 1
ratio, both pharmacological and clinical studies favour a 1 on 4 ratio. According to the
protocol ketofol 1 on 4 was prepared by mixing 1ml of ketamine (50mg) and 20ml of propofol
(200mg) in a single syringe and administrated as a loading dose of 1ml/10kg, followed by a
stepwise titration in aliquots of 0,5ml/10kg. Above 65 years the loading dose was halved.
An adult patient presenting at the investigating hospital in need of procedural sedation, who
agreed the informed consent for procedural sedation was treated according to this protocol.
Patients with an American Society of Anesthesiologist physical status classification system
status of III or more, with an anticipated difficult airway or intoxicated patients were
discussed with the anaesthesiology department to decide the feasibility of sedation in the
emergency ward setting. Pregnant patients were excluded.
Associated to this newly implemented protocol, an observational prospective study was
associated to verify the safety and effectivity, and to score the physicians satisfaction. A
separate informed consent was obtained for participation in the study to permit inclusion of
patient and procedural data into a registry. Data was registered by the physician responsible
for the sedation in a questionnaire. The investigators hypothesized the protocol with ketofol
in a 1 on 4 ratio would be safe and effective and would serve to facilitate procedural
sedation by emergency physicians.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01126957 -
Combined Ketamine/Propofol for Emergency Department Procedural Sedation
|
N/A | |
| Completed |
NCT01387139 -
Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
|
Phase 3 |