Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163969
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2005-09-12
Brief Title:
The Use of Ketamine as Rescue Analgesia in the Recovery Room Following Opioid Administration A Double-blind Randomised Trial in Postoperative Patients
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
The Use of Ketamine as Rescue Analgesia in the Recovery Room Following Opioid Administration A Double-blind Randomised Trial in Postoperative Patients
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial will determine if postoperative patients who have postoperative pain which has been refractory to morphine administration will have improved pain relief following a bolus administration of ketamine as compared with an ongoing morphine dosing regimen
Detailed Description:
Some patients require large doses of opioids to control postoperative pain which can result in a prolonged period of poor pain control and potentially increased side effects associated with large morphine doses This may be due to insufficient morphine dose to that individual or acute tolerance 1 Ketamine is not just an anaesthetic agent but at lower doses is known to provide efficacious analgesia 2 3 Ketamine has been shown to have a marked analgesic effect on high intensity nociceptive stimuli 4 as exhibited in postoperative pain When given for opioid analgesia resistant cancer pain in bolus doses at two different concentrations it has been shown to be effective and have a morphine-sparing effect without undue complications 5
Ketamine has been suggested to work pre-emptively and also by many other routes other than intravenously 6 - 9
Previous studies have compared morphine with morphine and ketamine administered as PCA or intramuscularly 10 - 12 in postoperative patients with varying effects Javery et al 11 showed that pain scores were lower in patients who received ketamine but Reeves et al in a later but similar study showed no significant difference 13
The authors have noted that in the postoperative situation with morphine resistant pain a bolus dose of ketamine not only leads to a marked decline in pain but it also remains efficacious for several hours This prolonged effect was also noted in opioid resistant cancer pain 5 This indeed may have relevance to the prevention of onset of chronic post surgical pain 14 and earlier discharge from the Post Anaesthetic Care Unit
Morphine and ketamine are not without side effects Respiratory depression nausea vomiting and vivid dreams being well documented will hence be a secondary endpoint A quality of recovery score will also be measured 15 and four hours postoperatively
This study is designed to compare a morphine regimen in the form of a standard Post Anaesthetic Care Unit pain protocol with a bolus dose of ketamine to be implemented if the pain protocol has been inadequate Any patient in pain despite two doses of morphine will be included Thereafter the patients will be randomised to receive either a further solution of ketamine or continuation of the morphine protocol This randomised double-blinded trial will be based in the Post Anaesthetic Care Unit under close anaesthetic and nursing staff supervision
Ketamine has been suggested to work pre-emptively and also by many other routes other than intravenously 6 - 9
Previous studies have compared morphine with morphine and ketamine administered as PCA or intramuscularly 10 - 12 in postoperative patients with varying effects Javery et al 11 showed that pain scores were lower in patients who received ketamine but Reeves et al in a later but similar study showed no significant difference 13
The authors have noted that in the postoperative situation with morphine resistant pain a bolus dose of ketamine not only leads to a marked decline in pain but it also remains efficacious for several hours This prolonged effect was also noted in opioid resistant cancer pain 5 This indeed may have relevance to the prevention of onset of chronic post surgical pain 14 and earlier discharge from the Post Anaesthetic Care Unit
Morphine and ketamine are not without side effects Respiratory depression nausea vomiting and vivid dreams being well documented will hence be a secondary endpoint A quality of recovery score will also be measured 15 and four hours postoperatively
This study is designed to compare a morphine regimen in the form of a standard Post Anaesthetic Care Unit pain protocol with a bolus dose of ketamine to be implemented if the pain protocol has been inadequate Any patient in pain despite two doses of morphine will be included Thereafter the patients will be randomised to receive either a further solution of ketamine or continuation of the morphine protocol This randomised double-blinded trial will be based in the Post Anaesthetic Care Unit under close anaesthetic and nursing staff supervision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None