Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202403689052671 Date of Approval: 28/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study of morphine, fentanyl or nalbuphine patient controlled analgesia for mucositis pain in pediatric patients undergoing cancer therapy: A randomized clinical trial
Official scientific title Comparative study of morphine, fentanyl or nalbuphine patient controlled analgesia for mucositis pain in pediatric patients undergoing cancer therapy: A randomized clinical trial
Brief summary describing the background and objectives of the trial Cancer treatment can bring a range of side effects, with severe oral mucositis being a significant concern. This condition causes pain, ulceration, and bleeding, significantly affecting patients. The severity of oral mucositis can be debilitating, hindering proper nutrition, requiring powerful analgesics, extending hospital stays, and raising treatment costs. Most importantly, it negatively affects the patients' quality of life. Children and adolescents are particularly vulnerable to developing severe oral mucositis, with younger children facing an even higher risk from chemotherapy. Roughly 40% of patients undergoing chemotherapy experience oral side effects, rising to over 90% in children under 12 years old. This study aimed to assess the safety and efficacy of nalbuphine, an opioid agonist/antagonist, compared to the pure opioid agonists morphine and fentanyl for treating severe oral mucositis pain in children undergoing cancer therapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 15/09/2018
Actual trial start date 15/09/2018
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date 28/02/2022
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nalbuphine patient controlled analgesia For 7 days from initiation of treatment Infusion was adjusted on a dose of 10 µg/kg/h IV as a background and 10 µg/kg IV bolus dose with 20 minutes lock-out, having the maximum allowed dose up to 40 µg/kg/h IV as a background and 40 µg/kg IV bolus dose with 20 min lockout. 30
Control Group Morphine patient controlled analgesia For 7 days from initiation of treatment Infusion was adjusted on a dose of 10 µg/kg/h IV as a background and 10 µg/kg IV bolus dose with 20 minutes lock-out, having the maximum allowed dose up to 40 µg/kg/h IV as a background and 40 µg/kg IV bolus dose with 20 min lockout. 30 Active-Treatment of Control Group
Control Group Fentanyl patient controlled analgesia For 7 days from initiation of treatment Infusion was adjusted on 0.1 µg/kg/h IV as a background and 0.1 µg/kg IV bolus dose with 20 minutes lockout having the maximum allowed dose up to 0.4 µg/kg/h IV as a background and 0.4 µg/kg IV bolus dose with 20 min lockout. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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) 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 Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 7 Year(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/09/2018 Research Ethics Committee of the Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia St. Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Adverse effects e.g. sedation, respiratory depression, bradycardia, hypotension, nausea, vomiting, pruritus, and urine retention. Over the first 7 days
Primary Outcome Pain intensity using the Visual Analog Scale baseline and every 12 hours over the first 7 days
Primary Outcome Number of active and total pushes of PCA buttons every 12 hours over the first 7 days
Primary Outcome Total opioid consumption every 12 hours over the first 7 days
Primary Outcome Patient satisfaction using the Patient Satisfaction Score At the end of the 7 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Children Cancer Hospital Egypt 57357 Sekat Hadid Al Mahger, Zeinhom, El Sayeda Zeinab Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hany Masoud Sekat Hadid Al Mahger, Zeinhom, El Sayeda Zeinab Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Childrens Cancer Hospital Egypt 57357 Sekat Hadid Al Mahger, Zeinhom, El Sayeda Zeinab Cairo Egypt Hospital
Primary Sponsor Ain Shams University Hospitals 38 Abbassia St. Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Masoud hany.g.masoud@email.com +201281186090 Sekat Hadid Al Mahger, Zeinhom, El Sayeda Zeinab
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Intensive Care and Pain Management Children Cancer Hospital Egypt 57357
Role Name Email Phone Street address
Scientific Enquiries Hany Masoud hany.g.masoud@email.com +201281186090 Sekat Hadid Al Mahger, Zeinhom, El Sayeda Zeinab
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Intensive Care and Pain Management Children Cancer Hospital Egypt 57357
Role Name Email Phone Street address
Public Enquiries Ahmed Ibrahim ahmed.ibrahim@email.com 00000000000000 38 Abbassia St.
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 36 months following article publication. Study Protocol From 12 to 36 months after article publication Data will be accessible on reasonable request from the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 18/03/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 18/03/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information