Effect of Intraperitoneal Bupivacaine with Dexmedotomidine or Fentanyl for Post-Operative Analgesia Following Laparoscopy in Pediatric Patients

NCT06694207 | Not Yet Recruiting

• 1 other identifier: Intraperitoneal Bupivacaine
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare analgesic effect of adding dexmedomedin or fentanyl to intraperitoneal bupivacain in pediatric patients undergoing laparoscopy. The primary outcome is to compare pain using the Children's Hospital of Eastern Ontario score (CHEOPS). The secondary goal is to compare the time to the first request for analgesia in the post-operative period, the total dose of analgesics used in the 24 hours (post-operative), side effects, and signs of systemic absorption and toxicity.

Conditions

Post Operative Analgesia

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to compare pain using the Children's Hospital of Eastern Ontario score (CHEOPS)

  compare the time to the first request for analgesia in the post-operative period, the total dose of analgesics used in the 24 hours (post-operative), side effects, and signs of systemic absorption and toxicity

  Baseline

Interventions

Intraperitoneal Bupivacaine with Dexmedotomidine or Fentanyl DRUG

Intraperitoneal Bupivacaine with Dexmedotomidine or Fentanyl for Post-Operative Analgesia Following Laparoscopy in Pediatric Patients

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This prospective study will include pediatric patients who will be admitted to hospitals of Assuit University including Children from both sexes, Children aged 6-9 years old, Have the American Society of Anesthesiologists (ASA) physical status I or II and those who will undergo laparoscopy.

You may qualify if:

• Who will undergo laparoscopy.

You may not qualify if:

• Children with a known history of Heart disease, Local anesthetic allergy, and Body mass index of ≥95th percentile for age.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Kaarthika T, Radhapuram SD, Samantaray A, Pasupuleti H, Hanumantha Rao M, Bharatram R. Comparison of effect of intraperitoneal instillation of additional dexmedetomidine or clonidine along with bupivacaine for post-operative analgesia following laparoscopic cholecystectomy. Indian J Anaesth. 2021 Jul;65(7):533-538. doi: 10.4103/ija.IJA_231_21. Epub 2021 Jul 23.

  PMID: 34321684 BACKGROUND

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Abanoub Yousef Roshdy, resident

CONTACT

00201202899180; Poopaa.yousef1234@gmail.com

Mohamed Sayed Hassanein, professor of Anesthesia

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wessam Nashaat Ali Mohamed

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11