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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06051630
Enrollment
62
Registered
2023-09-25
Start date
2023-10-01
Completion date
2024-01-01
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Peritonitis, Postoperative pain, Lidocaine, Burkina Faso

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.

Interventions

DRUGSerum saline intravenous

Perioperative serum saline intravenous administration

DRUGLidocaine intravenous

Perioperative lidocaine intravenous administration

Sponsors

Université NAZI BONI
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

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 saline

Eligibility

Sex/Gender
ALL
Age
6 Years to 15 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Resumption of transitUp 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 patienttime to first gas and/or presence of bowel sounds

Secondary

MeasureTime frameDescription
Analog visual scalePostoperative pain scores at 24 hoursAverage pain score, minimal value is 0, maximal value is 10 and higher score mean worse
Concentration of C-reactive proteinHours 24 postoperativeAverage of C-reactive protein
HospitalisationUp to 30 days during the postoperative period. From the date of randomization to the patient's discharge from hospital or date of deathNumber of days in hospital
Postoperative mortalityUp to 30 days during the postoperative period. From date of randomization to date of deathNumber of postoperative deaths

Contacts

Primary ContactBertille KI, Doctor
bertilleki@yahoo.fr+22670230257
Backup ContactIsmael GUIBLA, Doctor
ismaelguibla@gmail.com+22676135113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026