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Trial record 4 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

Magnesium Sulfate as an Adjuvant to Caudal Bupivacaine in Lower Abdominal Surgeries in Paediatrics.

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ClinicalTrials.gov Identifier: NCT03322878
Recruitment Status : Not yet recruiting
First Posted : October 26, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Magda saleh rezk, Cairo University

Brief Summary:

Intravenous magnesium has been studied in pediatrics to reduce agitation after sevoflurane anesthesia in children undergoing adenotonsillectomy, reduce intraoperative rocuronium requirements, prevent laryngospasm and coughing after removal of the endotracheal tube in patients undergoing adenotonsillectomy.

The aim of this study is to investigate the role of intravenous magnesium sulfate on postoperative pain management in paediatrics and to compare it with its effect when administered caudally in children undergoing lower abdominal surgeries.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Magnesium SO4 Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Intravenous Versus Caudal Magnesium Sulfate as an Adjuvant to Caudal Bupivacaine in Lower Abdominal Surgeries in Paediatrics Under General Anaesthesia
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous magnesium group (Group IV)
Group IV (n=30) will receive intravenous (IV) 20 ml magnesium SO4 (50 mg/ kg 10% MgSO4(magnesium sulphate) diluted in normal saline to a total volume of 20 ml(milliliter) ) and caudal anaesthesia using (bupivacaine 0.25% diluted in normal saline with total volume of 1 mL/kg) .
Drug: Magnesium SO4
The intravenous solutions (magnesium 10% for group IV or saline 0.9% for group CA and P) will be started then caudal block will be performed by the same anesthetist. Under complete aseptic conditions a caudal puncture with 5 cm short beveled 22 G caudal needle will be used in the lateral decubitus position. After identifying the space using the loss of resistance technique with saline, the study solutions will be injected slowly with repetitive intermittent aspiration.
Other Name: Caudal anaesthesia

Active Comparator: Caudal magnesium group (Group CA)
Group CA (n=30) will receive IV 20 ml normal saline and caudal anaesthesia using (bupivacaine 0.25% and 50 mg Magnesium SO4 diluted in normal saline with total volume of 1mL/kg).
Drug: Magnesium SO4
The intravenous solutions (magnesium 10% for group IV or saline 0.9% for group CA and P) will be started then caudal block will be performed by the same anesthetist. Under complete aseptic conditions a caudal puncture with 5 cm short beveled 22 G caudal needle will be used in the lateral decubitus position. After identifying the space using the loss of resistance technique with saline, the study solutions will be injected slowly with repetitive intermittent aspiration.
Other Name: Caudal anaesthesia

Placebo Comparator: Placebo group (Group P)
Group P (n=30) ) will receive IV 20 ml normal saline and caudal anaesthesia using (bupivacaine 0.25% diluted in normal saline with total volume of 1 mL/kg).
Drug: Magnesium SO4
The intravenous solutions (magnesium 10% for group IV or saline 0.9% for group CA and P) will be started then caudal block will be performed by the same anesthetist. Under complete aseptic conditions a caudal puncture with 5 cm short beveled 22 G caudal needle will be used in the lateral decubitus position. After identifying the space using the loss of resistance technique with saline, the study solutions will be injected slowly with repetitive intermittent aspiration.
Other Name: Caudal anaesthesia




Primary Outcome Measures :
  1. The analgesic effect of intravenous magnesium in children undergoing lower abdominal surgeries [ Time Frame: 12 hours ]

    Post operative pain score will be assessed using children's Hospital of Eastern Ontario Pain scale which is based on 6 criteria:

    • Crying
    • Facial expression
    • Child verbal expression
    • Torso (body position)
    • Touching or grabbing at wound
    • Legs position Criterion 1 is given a score of 1-3, criterion 2 and 3 are given a score of 0-2 while criterion 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ≤ than 8 indicate adequate analgesia.


Secondary Outcome Measures :
  1. Time to first rescue analgesia [ Time Frame: 12 hours ]
    Post operative first rescue analgesia time

  2. Post operative sedation score [ Time Frame: 30 minutes ]
    Sedation will be monitored after PACU arrival using Ramsay score : 1=fully awake , 2=drowsy but awakens spontaneously , 3=asleep but arouses and responds appropriately to simple verbal commands , 4=asleep,unresponsive to commands,but arouses to shoulder tap or loud verbal stimulus , 5=asleep and only responds to firm



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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 1 and 7 years, ASA(American Society of Anesthesiologists) physical status class |- || , patients scheduled for lower abdominal surgeries.

Exclusion Criteria:

  • patients with psychiatric disorders , children with cardiovascular,respiratory ,hepatic or renal dysfunction , known contraindications to regional anesthesia, ASA class |||- |V, hypersensitivity to magnesium or regular analgesic drugs.

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): NCT03322878


Contacts
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Contact: Magda S Rezk +20127812221 Gloria_gloria4@hotmail.com
Contact: Magda Elsharbatly +201278122220 Magdasaleh55@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Manal M El gohary Professor
Study Director: Amina A Ela Assistant professor
Study Chair: Heba M Nassar Assistant professor

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Responsible Party: Magda saleh rezk, Assistant lecturer, anesthesia department,Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03322878     History of Changes
Other Study ID Numbers: N-45 -2017
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

Keywords provided by Magda saleh rezk, Cairo University:
postoperative pain , pediatrics , magnesium sulfate

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Magnesium Sulfate
Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents