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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Lidocaine intravenous
* Drug: Serum saline intravenous


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>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 | Drug: Lidocaine intravenous<br>* Perioperative lidocaine intravenous administration<br>|
| Placebo Comparator: Saline group<br>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. | Drug: Serum saline intravenous<br>* Perioperative serum saline intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resumption of transit | time to first gas and/or presence of bowel sounds | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analog visual scale | Average pain score, minimal value is 0, maximal value is 10 and higher score mean worse | Postoperative pain scores at 24 hours | 
| Concentration of C-reactive protein | Average of C-reactive protein | Hours 24 postoperative | 
| Hospitalisation | Number of days in hospital | Up to 30 days during the postoperative period. From the date of randomization to the patient's discharge from hospital or date of death | 
| Postoperative mortality | Number of postoperative deaths | Up to 30 days during the postoperative period. From date of randomization to date of death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritonitis, Postoperative pain, Lidocaine, Burkina Faso