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The Use of Ketamine as Rescue Analgesia in the Recovery Room Following Opioid Administration. A Double-Blind Randomised Trial in Postoperative Patients
This study has been completed.
Study NCT00163969   Information provided by Bayside Health
First Received: September 12, 2005   Last Updated: October 10, 2006   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

September 12, 2005
October 10, 2006
April 2002
Pain scores at rest in recovery and at four hours postoperatively
Same as current
Complete list of historical versions of study NCT00163969 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
 
The Use of Ketamine as Rescue Analgesia in the Recovery Room Following Opioid Administration. A Double-Blind Randomised Trial in Postoperative Patients
The Use of Ketamine as Rescue Analgesia in the Recovery Room Following Opioid Administration. A Double-Blind Randomised Trial in Postoperative Patients.

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

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Post Operative Pain
Drug: ketamine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
September 2004
 

Inclusion Criteria:

  • 1. Those patients requiring the routine pain protocol to be implemented as used in the Post Anaesthetic Care Unit who need more than two doses of morphine (and having received intraoperative morphine).

Exclusion Criteria:

  • Exclusion Criteria

    1. Known allergy to morphine or ketamine.
    2. Past history of major psychiatric disturbance or currently taking psychiatric medication/s.
    3. Chronic morphine usage.
    4. Chronic pain syndrome or chronic painful medical condition.
    5. Unable to obtain a reliable pain score in recovery due to language barriers or residual anaesthesia.
    6. Known pregnancy.
    7. Cases where primary anaesthetist prefers alternate therapy.
    8. Aged less than 18 years.
    9. Weight less than 50 kilograms or greater than 100 kilograms.
    10. Use of ketamine intraoperatively.
    11. Use of major regional block.
Both
18 Years and older
No
 
Australia
 
 
NCT00163969
 
 
Bayside Health
 
Principal Investigator: David E Lindholm, MBBS FANZCA The Alfred
Bayside Health
September 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.