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Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine intravenous
Serum saline intravenous
Sponsored by
Université NAZI BONI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain focused on measuring Peritonitis, Postoperative pain, Lidocaine, Burkina Faso

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All patients aged 6 to 15, Classified according to the American Society of Anaesthesiologists (ASA) (I, II and III) admitted for peritonitis and whose parents have given informed consent Exclusion Criteria: State of shock Severe renal insufficiency (creatinine clearance less than 30 ml/min) History of allergy to lidocaine Refusal to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Lidocaine group

    Saline group

    Arm Description

    The group will receive 1.5 mg/kg lidocaine 2% bolus, followed by a continuous electric syringe dose of 1.5 mg/kg/hour intraoperatively, then 1.5 mg/kg/hour during the first 24 hours postoperatively

    The control group will receive an equivalent volume of saline: the volume of saline to be administered will be obtained by considering the dose of lidocaine 2% that the patient would have received if he/she had been in the interventional group.

    Outcomes

    Primary Outcome Measures

    Resumption of transit
    time to first gas and/or presence of bowel sounds

    Secondary Outcome Measures

    Analog visual scale
    Average pain score, minimal value is 0, maximal value is 10 and higher score mean worse
    Concentration of C-reactive protein
    Average of C-reactive protein
    Hospitalisation
    Number of days in hospital
    Postoperative mortality
    Number of postoperative deaths

    Full Information

    First Posted
    August 21, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Université NAZI BONI
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06051630
    Brief Title
    Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis
    Official Title
    Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université NAZI BONI

    4. Oversight

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

    5. Study Description

    Brief Summary
    Intravenous administration of lidocaine perioperatively after laparotomy for peritonitis could be an interesting alternative by reducing the duration of postoperative ileus, the intensity of pain and the patient's hospital stay, as well as the cost of management in our context of lack of financial, technical and human resources, hence the present study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Peritonitis, Postoperative pain, Lidocaine, Burkina Faso

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This will be a randomized, double-blind clinical trial conducted at University hospital Charles De Gaulle of Ouagadougou, comparing the results of intravenous administration of lidocaine perioperatively versus administration of saline
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine group
    Arm Type
    Experimental
    Arm Description
    The group will receive 1.5 mg/kg lidocaine 2% bolus, followed by a continuous electric syringe dose of 1.5 mg/kg/hour intraoperatively, then 1.5 mg/kg/hour during the first 24 hours postoperatively
    Arm Title
    Saline group
    Arm Type
    Placebo Comparator
    Arm Description
    The control group will receive an equivalent volume of saline: the volume of saline to be administered will be obtained by considering the dose of lidocaine 2% that the patient would have received if he/she had been in the interventional group.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine intravenous
    Intervention Description
    Perioperative lidocaine intravenous administration
    Intervention Type
    Drug
    Intervention Name(s)
    Serum saline intravenous
    Intervention Description
    Perioperative serum saline intravenous administration
    Primary Outcome Measure Information:
    Title
    Resumption of transit
    Description
    time to first gas and/or presence of bowel sounds
    Time Frame
    Up to 7 days during the postoperative period. From the date of randomization to the first postoperative gas and/or the presence of postoperative bowel sounds in the patient
    Secondary Outcome Measure Information:
    Title
    Analog visual scale
    Description
    Average pain score, minimal value is 0, maximal value is 10 and higher score mean worse
    Time Frame
    Postoperative pain scores at 24 hours
    Title
    Concentration of C-reactive protein
    Description
    Average of C-reactive protein
    Time Frame
    Hours 24 postoperative
    Title
    Hospitalisation
    Description
    Number of days in hospital
    Time Frame
    Up to 30 days during the postoperative period. From the date of randomization to the patient's discharge from hospital or date of death
    Title
    Postoperative mortality
    Description
    Number of postoperative deaths
    Time Frame
    Up to 30 days during the postoperative period. From date of randomization to date of death

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All patients aged 6 to 15, Classified according to the American Society of Anaesthesiologists (ASA) (I, II and III) admitted for peritonitis and whose parents have given informed consent Exclusion Criteria: State of shock Severe renal insufficiency (creatinine clearance less than 30 ml/min) History of allergy to lidocaine Refusal to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bertille KI, Doctor
    Phone
    +22670230257
    Email
    bertilleki@yahoo.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ismael GUIBLA, Doctor
    Phone
    +22676135113
    Email
    ismaelguibla@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nazinigouba OUEDRAOGO, Professor
    Organizational Affiliation
    JOSEPH KI-ZERBO University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis

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