Abdominal Surgeries, Nalbuphine, Pediatric Cancer, Tramadol
Conditions
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.
Interventions
DRUGNalbuphine
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)
DRUGTramadol
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).
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to first rescue analgesia | 72 hours | Time to first analgesic request( paracetamol) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactNorma Osama AbdAllah Zayed, MD
Outcome results
None listed