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NCT Number: NCT07110051

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

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

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Key information

Conditions

Tramadol Abdominal Surgeries Nalbuphine Neoplasms Pediatric Cancer

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National cancer institute

Cairo, 11769, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: nalufin

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).

Other names: tramal

Primary outcomes

  1. time to first rescue analgesia

    Time frame: 72 hours

    Time to first analgesic request( paracetamol)

Secondary outcomes

  1. Frequency of paracetamol consumption

    Time frame: 72 hours

    Postoperative paracetamol frequency

  2. Wong-barker faces pain rating scale score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Norma Osama AbdAllah Zayed, MD

CONTACT

[email protected]

01067843111

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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