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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-01-01

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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Lidocaine group

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

Group Type EXPERIMENTAL

Lidocaine intravenous

Intervention Type DRUG

Perioperative lidocaine intravenous administration

Saline group

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.

Group Type PLACEBO_COMPARATOR

Serum saline intravenous

Intervention Type DRUG

Perioperative serum saline intravenous administration

Interventions

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Lidocaine intravenous

Perioperative lidocaine intravenous administration

Intervention Type DRUG

Serum saline intravenous

Perioperative serum saline intravenous administration

Intervention Type DRUG

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes