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Multimodal Analgesia in Major Abdominal Pediatric Cancer Surgeries

Primary Purpose

Pediatric Cancer, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Paracetamol and ketamine
Caudal levobupivacaine
Morphine
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Cancer

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

  • Department of Anesthesia and Pain medicine.National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Drug: Morphine

Procedure/surgery:Caudal levobupivacaine

Drug: Paracetamol and ketamine

Arm Description

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.

Outcomes

Primary Outcome Measures

Total morphine consumption
Total morphine consumption during the postoperative 24 hours

Secondary Outcome Measures

Changes in VAS score for pain
it is a scoring system from 0 to 100 where 0 means no pain while 100 represents maximum pain.

Full Information

First Posted
June 23, 2018
Last Updated
July 9, 2018
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT03580980
Brief Title
Multimodal Analgesia in Major Abdominal Pediatric Cancer Surgeries
Official Title
Evaluation of Multimodal Preemptive Analgesia in Major Pediatric Abdominal Cancer Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer, Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: Morphine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Procedure/surgery:Caudal levobupivacaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Drug: Paracetamol and ketamine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paracetamol and ketamine
Other Intervention Name(s)
Multimodal
Intervention Description
intravenous paracetamol and ketamine followed by ketorolac
Intervention Type
Procedure
Intervention Name(s)
Caudal levobupivacaine
Other Intervention Name(s)
Epidural
Intervention Description
an epidural injection of morphine and levobupivacaine through the caudal space
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Patient controlled analgesia
Intervention Description
patient controlled analgesia by morphine
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
Total morphine consumption during the postoperative 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Changes in VAS score for pain
Description
it is a scoring system from 0 to 100 where 0 means no pain while 100 represents maximum pain.
Time Frame
Baseline and 6,12,18 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab H Shaker, MD
Organizational Affiliation
National Cancer Institute- Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia and Pain medicine.National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
after submission of the study it will be available for all researchers through the publication

Learn more about this trial

Multimodal Analgesia in Major Abdominal Pediatric Cancer Surgeries

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