Clinical Trial: The Use of Ketamine as Rescue Analgesia in the Recovery Room Following Opioid Administration. A Double-blind Randomised Trial in Postoperative Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of Ketamine as Rescue Analgesia in the Recovery Room Following Opioid Administration. A Double-blind Randomised Trial in Postoperative Patients.

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 Summary:

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
Sponsor: Bayside Health

Current Primary Outcome: Pain scores at rest in recovery and at four hours postoperatively

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Morphine protocol consumption.
  • Sedation scores - Recovery Room and four hours.
  • PONV scores - Recovery Room and four hours.
  • Frequency of antiemetic administration - Recovery Room and up to four hours.
  • Quality of recovery score preoperatively and at four hours.
  • Adverse events (vivid dreams, nausea, hallucinations, respiratory depression, pruritus) - Recovery Room and at four hours.
  • Time to discharge from the recovery room.


Original Secondary Outcome:

  • 1. Morphine protocol consumption.
  • 2. Sedation scores – Recovery Room and four hours.
  • 3. PONV scores – Recovery Room and four hours.
  • 4. Frequency of antiemetic administration – Recovery Room and up to four hours.
  • 5. Quality of recovery score preoperatively and at four hours.
  • 6. Adverse events (vivid dreams, nausea, hallucinations, respiratory depression, pruritus) – Recovery Room and at four hours.
  • 7. Time to discharge from the recovery room.


Information By: Bayside Health

Dates:
Date Received: September 12, 2005
Date Started: April 2002
Date Completion: September 2004
Last Updated: January 13, 2016
Last Verified: September 2005