Multimodal Analgesia in Major Abdominal Pediatric Cancer Surgeries

NCT03580980 | Completed

• 1 other identifier: Ehab-Hossam.multi
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Total morphine consumption during the postoperative 24 hours

  24 hours

Secondary Outcomes (1)

• Changes in VAS score for pain

  Baseline and 6,12,18 and 24 hours

Study Arms (3)

Drug: Morphine

ACTIVE COMPARATOR

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

Drug: Morphine

Procedure/surgery:Caudal levobupivacaine

ACTIVE COMPARATOR

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.

Procedure: Caudal levobupivacaine

Drug: Paracetamol and ketamine

ACTIVE COMPARATOR

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.

Drug: Paracetamol and ketamine

Interventions

Paracetamol and ketamine DRUG

intravenous paracetamol and ketamine followed by ketorolac

Also known as: Multimodal

Drug: Paracetamol and ketamine

Caudal levobupivacaine PROCEDURE

an epidural injection of morphine and levobupivacaine through the caudal space

Also known as: Epidural

Procedure/surgery:Caudal levobupivacaine

Morphine DRUG

patient controlled analgesia by morphine

Also known as: Patient controlled analgesia

Drug: Morphine

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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%).

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms; Pain, Postoperative

Interventions

Acetaminophen; Ketamine; Combined Modality Therapy; Injections, Epidural; Morphine; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Therapeutics; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; 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; Analgesia; Anesthesia and Analgesia

Study Officials

• Ehab H Shaker, MD

  National Cancer Institute- Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor of Anesthesia ,Critical care and Pain medicine

Study Record Dates

• First Submitted: June 23, 2018
• First Posted: July 10, 2018
• Study Start: April 1, 2015
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

EG (1)