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Completed

NCT Number: NCT03825887

Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients

Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled analgesia (PCA) for mucositis pain in pediatric cancer patients

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Key information

About this study

The investigators will compare between using of PCA Morphine (Group A) and using of PCA Nalbuphine (Group B) in the following items over the first 7 days of initiation:

  • Pain intensity VAS every 12 hours and during the performing of mouth care for each patient over the first 7 days.
  • Total opioid consumptions for each patient every 24 hours and the total consumption of the entire 7 days since initiation.
  • Number of active and total pushes of PCA buttons every 24 hours and the sum up of the active and total pushes of PCA buttons for each patient over the 7 days.
  • Patient satisfaction at the end of the 7 days. Patient satisfaction score PSS was assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14).
  • Serious adverse events. (Nausea and vomiting, pruritus, respiratory depression, urinary retention, sedation, bradycardia, hypotension).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed Primary AML or HSCT and ALL with oral mucositis grade III OR IV presenting in the study period.
  • Age above 5 year and below 18 years
  • Written Informed Consent from parents/guardian

Exclusion criteria

  • History of mental retardation
  • known or suspected allergy to any narcotics
  • Presence of any other co-morbidity:
  • kidney (Crcl <50)
  • liver (liver enzymes more than 10 folds)
  • chest (SPO2 <92% on room air)
  • cardiac disease (ejection fraction <40%)
  • terminal patients who scheduled for palliative care

Treatment and study plan

Nalbuphine

Drug

Nalbuphine (Group B): Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40mcg /kg/ hour.

Any patient will continue to complain of pain rating 4-6 on VAS after reaching the maximum designated dose (which is 40 mcg/kg/hour) will be transferred to the ICU for close monitoring according to the internal hospital guidelines and getting him/her out of the study.

There is no drug shifting at any part of the study.

Morphine

Drug

morphine (Group A): Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40mcg /kg/ hour.

Any patient will continue to complain of pain rating 4-6 on VAS after reaching the maximum designated dose (which is 40 mcg/kg/hour) will be transferred to the ICU for close monitoring according to the internal hospital guidelines and getting him/her out of the study.

There is no drug shifting at any part of the study.

Primary outcomes

  1. measure the change in Pain intensity

    Time frame: change occur every 12 hours and during the performing of mouth care for each patient over the first 7 days

    change in pain intensity by visual analogue scale (scale from 0 to 100)

  2. Total opioid consumptions

    Time frame: the total consumption through the entire 7 days since initiation

    total dosing in mg/day

Secondary outcomes

  1. Number of active and total pushes of PCA buttons

    Time frame: every 24 hours and the sum up of the active and total pushes of PCA buttons for each patient over the 7 days.

    Number of active and total pushes of PCA buttons

  2. Patient satisfaction: linear scale

    Time frame: at the end of the 7 days.

    Patient satisfaction score PSS was assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14).

  3. Assess serious adverse events

    Time frame: during 7 days of treatment only

    by reporting the number of patients with Nausea and vomiting and/or pruritus and/or respiratory depression and/or urinary retention and/or sedation and/or bradycardia and/or hypotension).

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study title

Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine Patient Controlled Analgesia (PCA) for Mucositis Pain in Pediatric Patients. A Prospective Randomized Double Blinded Clinical Trial

Acronym: PCA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2019
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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