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

Not Applicable

Recruiting

• Conditions: Tramadol; Nalbuphine; Abdominal Surgeries; Pediatric Cancer
• Interventions: Drug: Nalbuphine; Drug: Tramadol

• Registration Number: NCT07110051
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

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

Detailed Description

Pain is an important and complex protective phenomenon. Good postoperative pain relief is important as it alleviates patient distress and aids a rapid, uncomplicated recovery.

Nalbuphine is a semi-synthetic opioid analgesic that belongs to the phenanthrene family. It is commonly used for pain management in children, but is associated with certain side effects such as respiratory and central nervous system depression, emesis, and pruritus due to its effect on µ2 receptors. Tramadol is a potent analgesic that binds to µ1 and µ2 receptors and enhances the inhibitory action of descending pain pathways. In contrast to other opioids, including nalbuphine, tramadol does not induce tolerance and is associated with reduced adverse effects.

Therefore, in this study, investigators will compare the efficacy of nalbuphine and tramadol for the management of postoperative pain in cancer children after abdominal surgeries.

Study Timeline

• Study Start: 2025-01-15
• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-11
• Primary Completion: 2025-09-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nalbuphine (group A)	Nalbuphine	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)
Tramadol (group B)	Tramadol	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).

Primary Outcome Measures

Name	Time	Method
time to first rescue analgesia	72 hours	Time to first analgesic request( paracetamol)

Secondary Outcome Measures

Name	Time	Method
Frequency of paracetamol consumption	72 hours	Postoperative paracetamol frequency
Wong-barker faces pain rating scale score	72 hours	Wong-barker faces pain rating scale score will be measured every 8 hours. The Wong-Baker Faces Pain Rating Scale is a tool that uses a combination of faces, numbers, and words to help a person effectively communicate the severity of their physical pain.; The scale starts at 0 and ends at 10, with the numbers increasing in intervals of 2. Each number relates to both a face and a small descriptive phrase. It is flexible because if someone uses the numbers, they may not need the faces or the wording. The phrase relating to each numerical value is as follows: 0: no hurt or pain, 2: it hurts a little bit,4: it hurts a little more ,6: it hurts even more,8: it hurts a whole lot 10: it hurts the worst

Trial Locations

Locations (1)

National cancer institute; 🇪🇬 Cairo, Egypt