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

National Cancer Institute, Egypt

Status: Enrolling

Conditions: Abdominal Surgeries; Nalbuphine; Tramadol; Pediatric Cancer

Treatments: Drug: Tramadol; Drug: Nalbuphine

Study type: Interventional

Funder types: Other

Identifiers

NCT07110051

AP2403-301-015

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

nalbuphine (group A)

Active Comparator group

Description:

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)

Treatment:

Drug: Nalbuphine

Tramadol (group B)

Active Comparator group

Description:

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).

Treatment:

Drug: Tramadol