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Completed

NCT Number: NCT00163969

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Alfred Commercial Rd Prahran

Melbourne, Victoria, 3181, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Known allergy to morphine or ketamine.
  • Past history of major psychiatric disturbance or currently taking psychiatric medication/s.
  • Chronic morphine usage.
  • Chronic pain syndrome or chronic painful medical condition.
  • Unable to obtain a reliable pain score in recovery due to language barriers or residual anaesthesia.
  • Known pregnancy.
  • Cases where primary anaesthetist prefers alternate therapy.
  • Aged less than 18 years.
  • Weight less than 50 kilograms or greater than 100 kilograms.
  • Use of ketamine intraoperatively.
  • Use of major regional block.

Treatment and study plan

ketamine

Drug

Primary outcomes

  1. Pain scores at rest in recovery and at four hours postoperatively

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Sep 14, 2005
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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