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

NCT00163969 | Completed Phase 4

• 1 other identifier: 161/01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain

Keywords

Pain; Wind-up; opioid; ketamine; pre-emptive

Outcome Measures

Primary Outcomes (1)

• Pain scores at rest in recovery and at four hours postoperatively

Secondary Outcomes (7)

• 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.

Interventions

ketamine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

The Alfred Commercial Rd Prahran

Melbourne, Victoria, 3181, Australia

Location

Related Publications (15)

• 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.

  PMID: 11239748 BACKGROUND

• 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.

  PMID: 9895071 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11429351 BACKGROUND

• 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.

  PMID: 10895748 BACKGROUND

• 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.

  PMID: 8829857 BACKGROUND

• 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.

  PMID: 10655908 BACKGROUND

• 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.

  PMID: 10467917 BACKGROUND

• 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.

  PMID: 11094004 BACKGROUND

• 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.

  PMID: 10839912 BACKGROUND

• 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.

  PMID: 9366932 BACKGROUND

• 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.

  PMID: 11027905 BACKGROUND

• 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.

  PMID: 7598284 BACKGROUND

• 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.

  PMID: 3318543 BACKGROUND

• 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.

  PMID: 7459184 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• David E Lindholm, MBBS FANZCA

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: April 1, 2002
• Study Completion: September 1, 2004
• Last Updated: January 15, 2016

Record last verified: 2005-09

Locations

AU (1)