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

NCT ID: NCT07110051

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-10-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Tramadol Nalbuphine Abdominal Surgeries Pediatric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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nalbuphine (group A)

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)

Group Type ACTIVE_COMPARATOR

Nalbuphine

Intervention Type 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)

Tramadol (group B)

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).

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type 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).

Interventions

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Nalbuphine

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)

Intervention Type DRUG

Tramadol

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).

Intervention Type DRUG

Other Intervention Names

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nalufin tramal

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Norma Osama Abdalla Zayed

Lecturer of Anesthesia, Surgical ICU and Pain Management, National Cancer Institute, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reham mohamed gamal, MD

Role: PRINCIPAL_INVESTIGATOR

assistant professor

Locations

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National cancer institute

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Norma Osama AbdAllah Zayed, MD

Role: CONTACT

01067843111

Other Identifiers

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AP2403-301-015

Identifier Type: -

Identifier Source: org_study_id

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