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

Sponsor

Université NAZI BONI (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06051630

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Lidocaine intravenous Drug: Serum saline intravenous	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 salineThis 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 (Participant)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Lidocaine intravenous Perioperative lidocaine intravenous administration
Placebo Comparator: 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.	Drug: Serum saline intravenous Perioperative serum saline intravenous administration

Arm

Intervention/Treatment

Experimental: 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

Drug: Lidocaine intravenous

Perioperative lidocaine intravenous administration

Placebo Comparator: 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.

Drug: Serum saline intravenous

Perioperative serum saline intravenous administration

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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