Multimodal Analgesia in Major Abdominal Pediatric Cancer Surgeries

Ketamine

Brief Summary

Surgical trauma initiates multiple physiological mechanisms that cause postoperative pain. Postoperative pain has nociceptive, inflammatory, and neuropathic components.Inadequate relief of postoperative pain leads to significant morbidity, delayed recovery, and mortality.Adverse reactions of medications used for postoperative pain management, particularly opioids, are common including pruritus and nausea and vomiting.Preemptive analgesia is defined as analgesic treatment that starts before surgical incision to prevent central sensitization caused by incisional and inflammatory injuries.Therefore, in this pilot study, the investigators are trying to evaluate safety and efficacy of preemptive multimodal analgesia compared with preemptive caudal analgesia and PCA morphine in pediatric cancer patient undergoing major abdominal surgery.

Intervention / Treatment

  • Paracetamol and ketamine (DRUG)
    intravenous paracetamol and ketamine followed by ketorolac
  • Caudal levobupivacaine (PROCEDURE)
    an epidural injection of morphine and levobupivacaine through the caudal space
  • Morphine (DRUG)
    patient controlled analgesia by morphine

Condition or Disease

  • Pediatric Cancer
  • Pain, Postoperative

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 5 Years to 12 Years
    Enrollment: 90 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    SINGLE:
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2015 ACTUAL
    Primary Completion: Nov 30, 2017 ACTUAL
    Completion Date: Nov 30, 2017 ACTUAL
    Study First Posted: Jul 10, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 09, 2018

    Sponsors / Collaborators

    Lead Sponsor: National Cancer Institute, Egypt
    Responsible Party: N/A

    Location

    Cairo, Egypt

    Surgical trauma initiates multiple physiological mechanisms that cause postoperative pain. Postoperative pain has nociceptive, inflammatory, and neuropathic components.Inadequate relief of postoperative pain leads to significant morbidity, delayed recovery, and mortality.Despite the development of new drugs and analgesic techniques, up to 40% of hospitalized children - especially surgical patients - experiences moderate to severe pain. Adverse reactions of medications used for postoperative pain management, particularly opioids, are common including pruritus and nausea and vomiting.The incidence of opioid-related respiratory depression was reported to range from 0.11 to 0.41%.Regional anesthesia was suggested as an alternative to opioid-based analgesia in pediatric patients. Caudal epidural analgesia is a relatively safe and simple technique for postoperative pain management in children.However, there is a potential for adverse effects related to the technique of catheter placement or systemic toxicity of the local anesthetic.

    Preemptive analgesia is defined as analgesic treatment that starts before surgical incision to prevent central sensitization caused by incisional and inflammatory injuries.However, studies in animal models of incisional pain demonstrated that single analgesic treatment before the incision does not reduce postoperative pain. Once nociceptive afferent block subsides, the wound reinitiates central sensitization. Also, clinical trials reported similar results.Multimodal analgesia uses a combination of delivery routes administered at variable time points to optimize outcomes in the treatment of acute pain.

    Therefore, in this pilot study, the investigators are trying to evaluate safety and efficacy of preemptive multimodal analgesia compared with preemptive caudal analgesia and PCA morphine in pediatric cancer patient undergoing major abdominal surgery.

    Participant Groups

    • Morphine Group C (n=30) was the control group who received IV morphine in a dose of 0.1 mg/kg after induction of anesthesia

    • In Caudal Group (n=30), patients were placed in the lateral position and received caudal epidural block after induction of anesthesia with levobupivacaine 0.125% , 1.1 ml/kg and morphine 0.02 mg/kg with maximum 20ml.

    • The patients of Multimodal Group (n=30) received paracetamol infusion 10 mg/kg over 10 minutes and ketamine 0.5 mg/kg IV bolus followed by ketorolac 1 mg/kg infusion over 10 minutes.

    Eligibility Criteria

    Sex: All
    Minimum Age: 5
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * were ASA I or II patients.
    * Aged between 5 and 12 years.
    * Both sexes.
    * Scheduled for major abdominal surgery with a midline incision.

    Exclusion Criteria:

    * included history of mental retardation or delayed development that may interfere with pain intensity assessment,
    * Known or suspected allergy to any administered drugs.
    * Active renal (creatinine clearance \<50).
    * Hepatic (liver enzymes more than 10 folds).
    * Respiratory (SPO2 \<92% on room air).
    * Cardiac disease (ejection fraction \< 50%).

    Primary Outcomes

    • Total morphine consumption during the postoperative 24 hours

    Secondary Outcomes

    • it is a scoring system from 0 to 100 where 0 means no pain while 100 represents maximum pain.

    More Details

    NCT Number: NCT03580980
    Other IDs: Ehab-Hossam.multi
    Study URL: https://clinicaltrials.gov/study/NCT03580980
    Last updated: Sep 29, 2023