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

NCT06010056 | 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 postoperative 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: * very unsatisfied * unsatisfied * neutral * satisfied * very satisfied

  At 48 hours post operative

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:

• American Society of Anesthesiologists (ASA) I or II patients.
• Patients between 18- 70 years of age.
• Patients undergoing elective laparotomy colorectal surgery.

You may not qualify if:

• Patients with a known allergy to morphine or ketamine.
• Patients with uncontrolled hypertension.
• Patients with a past history of chronic pain on regular analgesics.
• Patients on psychiatric drugs.
• Patients with BMI more than 35.
• Patients with Creatinine Clearance \< 30

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (18)

• Momeni M, Crucitti M, De Kock M. Patient-controlled analgesia in the management of postoperative pain. Drugs. 2006;66(18):2321-37. doi: 10.2165/00003495-200666180-00005.

  PMID: 17181375 BACKGROUND

• McNicol ED, Ferguson MC, Hudcova J. Patient controlled opioid analgesia versus non-patient controlled opioid analgesia for postoperative pain. Cochrane Database Syst Rev. 2015 Jun 2;2015(6):CD003348. doi: 10.1002/14651858.CD003348.pub3.

  PMID: 26035341 BACKGROUND

• Macintyre PE. Safety and efficacy of patient-controlled analgesia. Br J Anaesth. 2001 Jul;87(1):36-46. doi: 10.1093/bja/87.1.36. No abstract available.

  PMID: 11460812 BACKGROUND

• Dolin SJ, Cashman JN. Tolerability of acute postoperative pain management: nausea, vomiting, sedation, pruritus, and urinary retention. Evidence from published data. Br J Anaesth. 2005 Nov;95(5):584-91. doi: 10.1093/bja/aei227. Epub 2005 Sep 16.

  PMID: 16169893 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

• Vadivelu N, Mitra S, Narayan D. Recent advances in postoperative pain management. Yale J Biol Med. 2010 Mar;83(1):11-25.

  PMID: 20351978 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

• Subramaniam K, Subramaniam B, Steinbrook RA. Ketamine as adjuvant analgesic to opioids: a quantitative and qualitative systematic review. Anesth Analg. 2004 Aug;99(2):482-95, table of contents. doi: 10.1213/01.ANE.0000118109.12855.07.

  PMID: 15271729 BACKGROUND

• Stoetling RK, Hiller SK. Pharmacology & Physiology in Anesthetic Practice. 4th edition. Philadelphia: Lippincott Williams & Wilkins. 2006.

  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

• Michelet P, Guervilly C, Helaine A, Avaro JP, Blayac D, Gaillat F, Dantin T, Thomas P, Kerbaul F. Adding ketamine to morphine for patient-controlled analgesia after thoracic surgery: influence on morphine consumption, respiratory function, and nocturnal desaturation. Br J Anaesth. 2007 Sep;99(3):396-403. doi: 10.1093/bja/aem168. Epub 2007 Jun 18.

  PMID: 17576969 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

• Kamal HM. Ketamine as an Adjuvant to Morphine for Patient Controlled Analgesia in Morbidly Obese Patients. Journal of Medical Sciences 2008; 8: 364-370.

  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

• Zakine J, Samarcq D, Lorne E, Moubarak M, Montravers P, Beloucif S, Dupont H. Postoperative ketamine administration decreases morphine consumption in major abdominal surgery: a prospective, randomized, double-blind, controlled study. Anesth Analg. 2008 Jun;106(6):1856-61. doi: 10.1213/ane.0b013e3181732776.

  PMID: 18499623 BACKGROUND

• Akhavanakbari G, Mohamadian A, Entezariasl M. Evaluation the effects of adding ketamine to morphine in intravenous patient-controlled analgesia after orthopedic surgery. Perspect Clin Res. 2014 Apr;5(2):85-7. doi: 10.4103/2229-3485.128028.

  PMID: 24741486 BACKGROUND

• Dahi-Taleghani M, Fazli B, Ghasemi M, Vosoughian M, Dabbagh A. Effect of intravenous patient controlled ketamine analgesiaon postoperative pain in opium abusers. Anesth Pain Med. 2014 Feb 15;4(1):e14129. doi: 10.5812/aapm.14129. eCollection 2014 Feb.

  PMID: 24701419 BACKGROUND

• Sveticic G, Gentilini A, Eichenberger U, Luginbuhl M, Curatolo M. Combinations of morphine with ketamine for patient-controlled analgesia: a new optimization method. Anesthesiology. 2003 May;98(5):1195-205. doi: 10.1097/00000542-200305000-00023.

  PMID: 12717142 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

• Yong C 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 18, 2023
• First Posted: August 24, 2023
• Study Start: April 5, 2018
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)