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Intrathecal Dexmedetomidine Versus Fentanyl With Bupivacaine in Children Undergoing Major Abdominal Cancer Surgery

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ClinicalTrials.gov Identifier: NCT02861716
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Rania Mohammed Abd elemam, South Egypt Cancer Institute

Brief Summary:
In this study the investigators aim to determine the analgesic effect and side effects of intrathecal fentanyl and dexmedetomidine as adjuvant to local anesthetics in pediatric patients undergoing major abdominal cancer surgeries.

Condition or disease Intervention/treatment Phase
Intrathecal Dexmedetomidine Pediatric Cancer Surgery Drug: Bupivacaine Drug: Fentanyl Drug: Dexmedetomidine Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intrathecal Dexmedetomidine Versus Fentanyl With Bupivacaine for Postoperative Analgesia in Children Undergoing Major Abdominal Cancer Surgery
Study Start Date : August 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fentanyl and dexmedetomidine
intrathecal bupivacaine (0.5%) 0.4mg/kg plus fentanyl and dexmedetomidine in 2ml volume will be injected slowly over 20 seconds.
Drug: Bupivacaine

premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.

After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight in 2ml volume and it will be injected slowly over 20 seconds.

Other Name: heavy marcaine

Active Comparator: dexmedetomidine and placebo for fentanyl
intrathecal bupivacaine (0.5%) 0.4mg/kg plus dexmedetomidine 0.2 μg/kg in 2ml volume and placebo (for fentanyl 0.2 μg/kg) it will be injected slowly over 20 seconds.
Drug: Bupivacaine

premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.

After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight in 2ml volume and it will be injected slowly over 20 seconds.

Other Name: heavy marcaine

Drug: Dexmedetomidine

premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.

After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight plus dexmedetomidine 0.2 μg/kg in 2ml volume and it will be injected slowly over 20 seconds.

Other Name: precedex

Active Comparator: fentanyl and placebo for dexmedetomidine
intrathecal bupivacaine (0.5%) 0.4mg/kg plus fentanyl 0.2 μg/kg in 2ml volume and placebo (for dexmedetomidine 0.2 μg/kg) it will be injected slowly over 20 seconds.
Drug: Bupivacaine

premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.

After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight in 2ml volume and it will be injected slowly over 20 seconds.

Other Name: heavy marcaine

Drug: Fentanyl

premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.

After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight plus fentanyl 0.2 μg/kg in 2ml volume and it will be injected slowly over 20 seconds.





Primary Outcome Measures :
  1. Pain by Face, Legs, Activity, Crying, and Consolability (FLACC) Pain Score [ Time Frame: one day ]
    FLA CC pain score will be assessed immediately postoperative and then every 2 hours. Each item is scored 0 to 2, yielding a total between 0 and10


Secondary Outcome Measures :
  1. Recurrence of pain [ Time Frame: 24 hours ]
    return of any pain during the specified post-dose period



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I and II
  • Patients scheduled for major abdominal cancer surgeries, expected to last more than 90 minutes

Exclusion Criteria:

  • Sacral bone abnormalities
  • Spina bifida
  • Coagulopathy
  • Mental delay or retardation
  • Known allergy to the study drugs
  • Local infection at the site of injection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861716


Contacts
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Contact: khaled fares, professor 002/01289757288 faressali@yahoo.com
Contact: sahar Mohammed, professor 002/01003611410 drsaher2008@yahoo.com

Locations
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Egypt
South Egypt Cancer Institute Recruiting
Assuit, Egypt, 5555
Contact: khaled fares, professor    01289757288    faressali@yahoo.com   
Contact: sahar abdelbaky, professor    01003611410    drsaher2008@yahoo.com   
Sponsors and Collaborators
South Egypt Cancer Institute
Investigators
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Principal Investigator: rania abdelemam, lecturer South Egypt Cancer Institute

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Responsible Party: Rania Mohammed Abd elemam, Director, Clinical Research, South Egypt Cancer Institute
ClinicalTrials.gov Identifier: NCT02861716     History of Changes
Other Study ID Numbers: Prospective
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary outcome measures will be made available within 6 months of study completion

Additional relevant MeSH terms:
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Bupivacaine
Fentanyl
Dexmedetomidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General