Multimodal Analgesia in Major Abdominal Pediatric Cancer Surgeries

NCT ID: NCT03580980

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2017-11-30

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.

Conditions

Pediatric Cancer; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Drug: Morphine

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

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

patient controlled analgesia by morphine

Procedure/surgery:Caudal levobupivacaine

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.

Group Type: ACTIVE_COMPARATOR

Caudal levobupivacaine

Intervention Type: PROCEDURE

an epidural injection of morphine and levobupivacaine through the caudal space

Drug: Paracetamol and ketamine

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.

Group Type: ACTIVE_COMPARATOR

Paracetamol and ketamine

Intervention Type: DRUG

intravenous paracetamol and ketamine followed by ketorolac

Interventions

Paracetamol and ketamine

intravenous paracetamol and ketamine followed by ketorolac

Intervention Type: DRUG

Caudal levobupivacaine

an epidural injection of morphine and levobupivacaine through the caudal space

Intervention Type: PROCEDURE

Morphine

patient controlled analgesia by morphine

Intervention Type: DRUG

Other Intervention Names

Multimodal; Epidural; Patient controlled analgesia

Eligibility Criteria

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%).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Ehab Hanafy Shaker

Clinical professor of Anesthesia ,Critical care and Pain medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ehab H Shaker, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute- Cairo University

Locations

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, , Egypt

Countries

Egypt

Related Links

http://onlinelibrary.wiley.com/doi/abs/10.1016/j.eujps.2011.08.013

Preventing chronic pain following acute pain: Risk factors, preventive strategies, and their efficacy

Other Identifiers

Ehab-Hossam.multi

Identifier Type: -

Identifier Source: org_study_id