Comparative study of morphine, fentanyl or nalbuphine patient controlled analgesia for mucositis pain in pediatric patients undergoing cancer therapy: A randomized clinical trial

Phase 2

• Conditions: Anaesthesia

• Registration Number: PACTR202403689052671
• Lead Sponsor: Childrens Cancer Hospital Egypt 57357

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-04
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

both sexes
aged 7-18 years
admitted to the Children Cancer Hospital Egypt 57357
diagnosed with cancer
and undergoing cancer therapy complicated by mucositis grade 3 and 4 (severe oral mucositis)

Exclusion Criteria

central nervous system disorders, delayed developmental milestones, or mental retardation that might interfere with the assessment of pain intensity
known or suspected myopathy
known or suspected allergy to any narcotic
known history of intolerable side effects of opioids
renal impairment (creatinine clearance less than 50 mL/min)
hepatic dysfunction (liver enzymes elevated more than 10-fold)
respiratory distress (SPO2 less than 92% on room air)
cardiac disease (ejection fraction less than 40%)
chronic pain complaints
advanced or metastatic cancer scheduled for palliative care

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity using the Visual Analog Scale;Number of active and total pushes of PCA buttons;Total opioid consumption;Patient satisfaction using the Patient Satisfaction Score

Secondary Outcome Measures

Name	Time	Method
Adverse effects e.g. sedation, respiratory depression, bradycardia, hypotension, nausea, vomiting, pruritus, and urine retention.