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Multimodal Analgesia in Major Abdominal Pediatric Cancer Surgeries

Evaluation of Multimodal Preemptive Analgesia in Major Pediatric Abdominal Cancer Surgeries

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03580980
Enrollment
90
Registered
2018-07-10
Start date
2015-04-01
Completion date
2017-11-30
Last updated
2018-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Pediatric Cancer

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.

Detailed description

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.

Interventions

DRUGParacetamol and ketamine

intravenous paracetamol and ketamine followed by ketorolac

PROCEDURECaudal levobupivacaine

an epidural injection of morphine and levobupivacaine through the caudal space

DRUGMorphine

patient controlled analgesia by morphine

Sponsors

National Cancer Institute, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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%).

Design outcomes

Primary

MeasureTime frameDescription
Total morphine consumption24 hoursTotal morphine consumption during the postoperative 24 hours

Secondary

MeasureTime frameDescription
Changes in VAS score for painBaseline and 6,12,18 and 24 hoursit is a scoring system from 0 to 100 where 0 means no pain while 100 represents maximum pain.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026