Nalbuphine Versus Tramadol on Post Operative Analgesia in Abdominal Surgery on Pediatric Cancer Patient

NCT07110051 | Recruiting

• 1 other identifier: AP2403-301-015
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

In current study the investigators aim to compare between nalbuphine versus tramadol for post-operative pain control in abdominal surgeries in pediatric.

Conditions

Tramadol; Nalbuphine; Abdominal Surgeries; Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• time to first rescue analgesia

  Time to first analgesic request( paracetamol)

  72 hours

Secondary Outcomes (2)

• Frequency of paracetamol consumption

  72 hours

• Wong-barker faces pain rating scale score

  72 hours

Study Arms (2)

nalbuphine (group A)

ACTIVE COMPARATOR

group A (nalbuphine) will receive a single dose of nalbuphine (0.2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours)

Drug: Nalbuphine

Tramadol (group B)

ACTIVE COMPARATOR

group B( Tramadol) will receive a single dose of tramadol (2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours).

Drug: Tramadol

Interventions

Nalbuphine DRUG

this group will a single dose of nalbuphine (0.2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours)

Also known as: nalufin

nalbuphine (group A)

Tramadol DRUG

this group will receive a single dose of tramadol (2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours).

Also known as: tramal

Tramadol (group B)

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants will be children aged 3-12 years
• American society of anesthesia (ASA) classification I-III.
• scheduled for elective Abdominal surgery under general anesthesia

You may not qualify if:

• child guardian refusal.
• Allergy from Tramal or nalbuphine
• Patient with previous chronic pain on opioids

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National cancer institute

Cairo, 11769, Egypt

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Nalbuphine; Tramadol

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Reham mohamed gamal, MD

  assistant professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norma Osama AbdAllah Zayed, MD

CONTACT

01067843111; norma.osama@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical ICU and Pain Management, National Cancer Institute, Cairo University

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: January 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 15, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for 6 months
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)