PCA Ketamine-Morphine VS PCA Morphine as Post-Operative Analgesia in Colorectal Surgery

NCT06021717 | Completed Phase 4

• 1 other identifier: JEP-2018-092
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness of PCA ketamine-morphine versus conventional PCA morphine in postoperative patients undergoing elective laparotomy colorectal surgery under general anaesthesia. The specific objectives are:

1. 1.To compare the post-operative analgesic requirement with PCA ketamine-morphine in comparison with PCA morphine.
2. 2.To compare the postoperative pain scores between PCA ketamine-morphine and PCA morphine.
3. 3.To assess patients' overall satisfaction with PCA ketamine-morphine in comparison with PCA morphine.
4. 4.To study the incidence of side effects of PCA ketamine-morphine in comparison with PCA morphine.

Conditions

Ketamine; Morphine

Keywords

Colorectal surgery; patient-controlled analgesia; postoperative pain management

Outcome Measures

Primary Outcomes (4)

• PCA drugs demanded and delivered

  Total PCA drugs demanded and delivered

  30 minutes after commencement of PCA until 48 hours

• Pain score

  Pain score at rest and on movement with NRS Numerical Rating Scale (NRS) for pain score assessment A numerical pain assessment tool from 0 to 10, where 0 denotes no pain, 5 denotes moderate pain and 10 denotes worst possible pain.

  30 minutes after commencement of PCA until 48 hours

• Incidence of side effects

  * Opiod related side effects : nausea and vomiting, pruritus, dizziness, respiratory depression and treatment on PRN basis if indicated * Ketamine related side effects : delirium, hallucinations, hypertension, tachycardia

  30 minutes after commencement of PCA until 48 hours

• Patients' overall satisfaction

  Assessment of patients' overall satisfaction with a 5-points scales at 48 hours. A 5-point scale from 1 to 5, where: 1. = very unsatisfied 2. = unsatisfied 3. = neutral 4. = satisfied 5. = very satisfied

  At 48 hours post oeprative

Study Arms (2)

Group A

EXPERIMENTAL

PCA ketamine (Ketamine HCl, Pfizer Inc., US) 0.5 mg plus morphine 0.5 mg ml-1 (ratio 1:1) as postoperative analgesia.

Drug: Ketamine-Morphine

Group B

ACTIVE COMPARATOR

PCA morphine (Pfizer Inc., US) 1 mg ml-1 as postoperative analgesia.

Drug: Morphine

Interventions

Ketamine-Morphine DRUG

PCA ketamine (Ketamine HCl, Pfizer Inc., US) 0.5 mg plus morphine 0.5 mg ml-1 (ratio 1:1)

Also known as: Ketamine Hydrochloric, Pfizer Inc., US, Morphine Pfizer Inc., US

Group A

Morphine DRUG

PCA morphine (Pfizer Inc., US) 1 mg ml-1

Also known as: Morphine Pfizer Inc., US

Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective American Society of Anaesthesiologists (ASA) I or II patients scheduled for lower midline laparotomy colorectal surgery aged between 18-70 years old

You may not qualify if:

• Patients with a known allergy to morphine or ketamine, uncontrolled hypertension, past history of chronic pain on regular analgesics, psychiatric illness on psychiatric drugs, BMI more than 35 and creatine clearance less than 30.

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (15)

• Pouldar TM, Maher DP, Betz AW, Wiegers JJ, Friedman JA, Zaidi SS, Rejali A, Tran HP, Yumul R, Louy C. Adverse Effects Associated with Patient-Controlled Analgesia with Ketamine Combined with Opioids and Ketamine Infusion with PCA Bolus in Postoperative Spine Patients: A Retrospective Review. J Pain Res. 2022 Oct 10;15:3127-3135. doi: 10.2147/JPR.S358770. eCollection 2022.

  PMID: 36247824 BACKGROUND

• Ragazzoni L, Kwizera A, Caviglia M, Bodas M, Franc JM, Ssemmanda H, Ripoll-Gallardo A, Della-Corte F, Alenyo-Ngabirano A. Intra-operative low-dose ketamine does not reduce the cost of post-operative pain management after surgery: a randomized controlled trial in a low-income country. Afr Health Sci. 2019 Dec;19(4):3127-3135. doi: 10.4314/ahs.v19i4.35.

  PMID: 32127889 BACKGROUND

• Viderman D, Tapinova K, Nabidollayeva F, Tankacheev R, Abdildin YG. Intravenous versus Epidural Routes of Patient-Controlled Analgesia in Abdominal Surgery: Systematic Review with Meta-Analysis. J Clin Med. 2022 May 5;11(9):2579. doi: 10.3390/jcm11092579.

  PMID: 35566705 BACKGROUND

• Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001 Aug;45(7):795-804. doi: 10.1034/j.1399-6576.2001.045007795.x.

  PMID: 11472277 BACKGROUND

• Argoff CE. Recent management advances in acute postoperative pain. Pain Pract. 2014 Jun;14(5):477-87. doi: 10.1111/papr.12108. Epub 2013 Aug 15.

  PMID: 23945010 BACKGROUND

• Hansen KB, Yi F, Perszyk RE, Furukawa H, Wollmuth LP, Gibb AJ, Traynelis SF. Structure, function, and allosteric modulation of NMDA receptors. J Gen Physiol. 2018 Aug 6;150(8):1081-1105. doi: 10.1085/jgp.201812032. Epub 2018 Jul 23.

  PMID: 30037851 BACKGROUND

• Simonini A, Brogi E, Cascella M, Vittori A. Advantages of ketamine in pediatric anesthesia. Open Med (Wars). 2022 Jul 6;17(1):1134-1147. doi: 10.1515/med-2022-0509. eCollection 2022.

  PMID: 35859796 BACKGROUND

• Brinck ECV, Virtanen T, Makela S, Soini V, Hynninen VV, Mulo J, Savolainen U, Rantakokko J, Maisniemi K, Liukas A, Olkkola KT, Kontinen V, Tarkkila P, Peltoniemi M, Saari TI. S-ketamine in patient-controlled analgesia reduces opioid consumption in a dose-dependent manner after major lumbar fusion surgery: A randomized, double-blind, placebo-controlled clinical trial. PLoS One. 2021 Jun 7;16(6):e0252626. doi: 10.1371/journal.pone.0252626. eCollection 2021.

  PMID: 34097713 BACKGROUND

• Zhou L, Yang H, Hai Y, Cheng Y. Perioperative Low-Dose Ketamine for Postoperative Pain Management in Spine Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Res Manag. 2022 Mar 31;2022:1507097. doi: 10.1155/2022/1507097. eCollection 2022.

  PMID: 35401887 BACKGROUND

• Wang L, Johnston B, Kaushal A, Cheng D, Zhu F, Martin J. Ketamine added to morphine or hydromorphone patient-controlled analgesia for acute postoperative pain in adults: a systematic review and meta-analysis of randomized trials. Can J Anaesth. 2016 Mar;63(3):311-25. doi: 10.1007/s12630-015-0551-4. Epub 2015 Dec 10.

  PMID: 26659198 BACKGROUND

• Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20.

  PMID: 21773855 BACKGROUND

• Carstensen M, Moller AM. Adding ketamine to morphine for intravenous patient-controlled analgesia for acute postoperative pain: a qualitative review of randomized trials. Br J Anaesth. 2010 Apr;104(4):401-6. doi: 10.1093/bja/aeq041. Epub 2010 Mar 5.

  PMID: 20207747 BACKGROUND

• Ghanavatian S, James DL, Sadolf JS. The role of short-term, low dose intravenous ketamine infusion in Calciphylaxis. CEN Case Rep. 2021 Aug;10(3):422-425. doi: 10.1007/s13730-020-00557-8. Epub 2021 Feb 19.

  PMID: 33606191 BACKGROUND

• Mathews TJ, Churchhouse AM, Housden T, Dunning J. Does adding ketamine to morphine patient-controlled analgesia safely improve post-thoracotomy pain? Interact Cardiovasc Thorac Surg. 2012 Feb;14(2):194-9. doi: 10.1093/icvts/ivr081. Epub 2011 Nov 28.

  PMID: 22159259 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

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Chian Yong Liu, MMed (Anaes)

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patients, nurses who cared for the patients, the anesthetist who performed the anesthesia and the investigators who gathered the data were blinded to patients' group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly allocated into either Group A or Group B by computer-generated randomization a day before planned surgery. Group A will receive PCA ketamine-morphine 0.5 mg/ml in 1:1 ratio while group B will receive PCA morphine 1mg/ml,

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: April 5, 2018
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: September 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)