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Post Operative PainPhase 4NCT00163969

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

A Phase 4 study testing ketamine in people with Post Operative Pain, run by Bayside Health at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Operative Pain
What is being tested?
ketamine
How many people
40 participants
Where
1 siteAustralia
Study dates
Apr 2002to Sep 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The Alfred Commercial Rd Prahran

    Melbourne, Victoria, 3181

Other trials in Australia

About this study

Official title: 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

Read the 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.

Being tested
ketamine
Keywords
Pain, Wind-up, opioid, ketamine, pre-emptive
Medical subject headings
Pain, Postoperative, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startApr 2002
  3. Study completionSep 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00163969
Sponsor's protocol ID
161/01
Status last verified
Sep 2005
First submitted
12 Sep 2005
Last updated
15 Jan 2016
Results posted
No

Publications

  • Mercadante S, Portenoy RK. Opioid poorly-responsive cancer pain. Part 2: basic mechanisms that could shift dose response for analgesia. J Pain Symptom Manage. 2001 Mar;21(3):255-64. doi: 10.1016/s0885-3924(00)00236-0.

    PubMed 11239748

  • Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.

    PubMed 9895071

  • Macrae W A, Davies H T O Chronic post surgical pain Epidemiology of Pain edited by Crombie I K. IASP Press. Seattle 1999. 125 - 142

  • Reeves M, Lindholm DE, Myles PS, Fletcher H, Hunt JO. Adding ketamine to morphine for patient-controlled analgesia after major abdominal surgery: a double-blinded, randomized controlled trial. Anesth Analg. 2001 Jul;93(1):116-20. doi: 10.1097/00000539-200107000-00025.

    PubMed 11429351

  • Marcus RJ, Victoria BA, Rushman SC, Thompson JP. Comparison of ketamine and morphine for analgesia after tonsillectomy in children. Br J Anaesth. 2000 Jun;84(6):739-42. doi: 10.1093/oxfordjournals.bja.a013585.

    PubMed 10895748

  • Javery KB, Ussery TW, Steger HG, Colclough GW. Comparison of morphine and morphine with ketamine for postoperative analgesia. Can J Anaesth. 1996 Mar;43(3):212-5. doi: 10.1007/BF03011736.

    PubMed 8829857

  • Adriaenssens G, Vermeyen KM, Hoffmann VL, Mertens E, Adriaensen HF. Postoperative analgesia with i.v. patient-controlled morphine: effect of adding ketamine. Br J Anaesth. 1999 Sep;83(3):393-6. doi: 10.1093/bja/83.3.393.

    PubMed 10655908

  • Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review of current techniques and outcomes. Pain. 1999 Aug;82(2):111-125. doi: 10.1016/S0304-3959(99)00044-5.

    PubMed 10467917

  • Azevedo VM, Lauretti GR, Pereira NL, Reis MP. Transdermal ketamine as an adjuvant for postoperative analgesia after abdominal gynecological surgery using lidocaine epidural blockade. Anesth Analg. 2000 Dec;91(6):1479-82. doi: 10.1097/00000539-200012000-00034.

    PubMed 11094004

  • Aida S, Yamakura T, Baba H, Taga K, Fukuda S, Shimoji K. Preemptive analgesia by intravenous low-dose ketamine and epidural morphine in gastrectomy: a randomized double-blind study. Anesthesiology. 2000 Jun;92(6):1624-30. doi: 10.1097/00000542-200006000-00020.

    PubMed 10839912

  • Stubhaug A, Breivik H, Eide PK, Kreunen M, Foss A. Mapping of punctuate hyperalgesia around a surgical incision demonstrates that ketamine is a powerful suppressor of central sensitization to pain following surgery. Acta Anaesthesiol Scand. 1997 Oct;41(9):1124-32. doi: 10.1111/j.1399-6576.1997.tb04854.x.

    PubMed 9366932

  • Mercadante S, Arcuri E, Tirelli W, Casuccio A. Analgesic effect of intravenous ketamine in cancer patients on morphine therapy: a randomized, controlled, double-blind, crossover, double-dose study. J Pain Symptom Manage. 2000 Oct;20(4):246-52. doi: 10.1016/s0885-3924(00)00194-9.

    PubMed 11027905

  • Arendt-Nielsen L, Petersen-Felix S, Fischer M, Bak P, Bjerring P, Zbinden AM. The effect of N-methyl-D-aspartate antagonist (ketamine) on single and repeated nociceptive stimuli: a placebo-controlled experimental human study. Anesth Analg. 1995 Jul;81(1):63-8. doi: 10.1097/00000539-199507000-00013.

    PubMed 7598284

  • Owen H, Reekie RM, Clements JA, Watson R, Nimmo WS. Analgesia from morphine and ketamine. A comparison of infusions of morphine and ketamine for postoperative analgesia. Anaesthesia. 1987 Oct;42(10):1051-6. doi: 10.1111/j.1365-2044.1987.tb05167.x.

    PubMed 3318543

  • Clements JA, Nimmo WS. Pharmacokinetics and analgesic effect of ketamine in man. Br J Anaesth. 1981 Jan;53(1):27-30. doi: 10.1093/bja/53.1.27.

    PubMed 7459184

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ketamine in people with Post Operative Pain, run by Bayside Health at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain scores at rest in recovery and at four hours postoperatively. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00163969, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.

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