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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163969

Registration number

NCT00163969

Ethics application status

Date submitted

12/09/2005

Date registered

14/09/2005

Date last updated

15/01/2016

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

161/01

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post Operative Pain

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Pain scores at rest in recovery and at four hours postoperatively

Timepoint [1]

Secondary outcome [1]

Morphine protocol consumption.

Timepoint [1]

Secondary outcome [2]

Sedation scores - Recovery Room and four hours.

Timepoint [2]

Secondary outcome [3]

PONV scores - Recovery Room and four hours.

Timepoint [3]

Secondary outcome [4]

Frequency of antiemetic administration - Recovery Room and up to four hours.

Timepoint [4]

Secondary outcome [5]

Quality of recovery score preoperatively and at four hours.

Timepoint [5]

Secondary outcome [6]

Adverse events (vivid dreams, nausea, hallucinations, respiratory depression, pruritus) - Recovery Room and at four hours.

Timepoint [6]

Secondary outcome [7]

Time to discharge from the recovery room.

Timepoint [7]

Eligibility

Key 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).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/04/2002

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred Commercial Rd Prahran - Melbourne

Recruitment postcode(s) [1]

3181 - Melbourne

Funding & Sponsors

Primary sponsor type

Government body

Name

Bayside Health

Address

Country

Ethics approval

Ethics application status

Summary

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

Trial website

https://clinicaltrials.gov/study/NCT00163969

Trial related presentations / 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Public notes

Contacts

Principal investigator

Name

David E Lindholm, MBBS FANZCA

Address

The Alfred

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00163969

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163969