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

ConditionsTramadolNalbuphineAbdominal SurgeriesPediatric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorNational Cancer Institute, Egypt

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants will be children aged 3-12 years

American society of anesthesia (ASA) classification I-III.

scheduled for elective Abdominal surgery under general anesthesia

Disqualifiers

child guardian refusal.

Allergy from Tramal or nalbuphine

Patient with previous chronic pain on opioids

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • 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).

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: nalbuphine (group A)Active comparator 1 intervention
Group B: Tramadol (group B)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

time to first rescue analgesia

Time to first analgesic request( paracetamol)

Time frame
72 hours

Secondary outcomes

1

Frequency of paracetamol consumption

Postoperative paracetamol frequency

Time frame
72 hours
2

Wong-barker faces pain rating scale score

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

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute, Egypt

Lead sponsor

Source ClinicalTrials.gov
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