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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06051630
• Other study ID #: INSSA 3
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2023
• Source: Université NAZI BONI
• Contact: Bertille KI, Doctor
• Phone: +22670230257
• Email: bertilleki[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: January 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Peritonitis
• Postoperative Pain

Intervention

Drug:
• Lidocaine intravenous
Perioperative lidocaine intravenous administration
• Serum saline intravenous
Perioperative serum saline intravenous administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université NAZI BONI

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Concentration of C-reactive protein	Average of C-reactive protein	Hours 24 postoperative
Secondary	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
Secondary	Postoperative mortality	Number of postoperative deaths	Up to 30 days during the postoperative period. From date of randomization to date of death