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Completed

NCT Number: NCT03580980

Multimodal Analgesia in Major Abdominal Pediatric Cancer Surgeries

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

Paracetamol and ketamine

Drug

intravenous paracetamol and ketamine followed by ketorolac

Other names: Multimodal

Caudal levobupivacaine

Procedure

an epidural injection of morphine and levobupivacaine through the caudal space

Other names: Epidural

Morphine

Drug

patient controlled analgesia by morphine

Other names: Patient controlled analgesia

Primary outcomes

  1. Total morphine consumption

    Time frame: 24 hours

    Total morphine consumption during the postoperative 24 hours

Secondary outcomes

  1. Changes in VAS score for pain

    Time frame: Baseline and 6,12,18 and 24 hours

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

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

Evaluation of Multimodal Preemptive Analgesia in Major Pediatric Abdominal Cancer Surgeries

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 10, 2018
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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