الفهرس 
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Abstract
This was a Randomized Clinical Trial conducted on
90 patients; to compare the efficacy and safety of Nalbuphine with pure opioid agonists (Morphine and Fentanyl) when used for mucositis pain in pediatric patients undergoing cancer therapy.
A total of 90 Pediatric patients who were diagnosed with cancer, and underwent cancer therapy that was complicated with Mucositis grade III – IV WHO scale for oral mucositis were enrolled in the study.
The study enrolled patients who were admitted to Children Cancer Hospital -Egypt (CCH E-57357) randomly allocated, using a computer-generated sequence of numbers, into 3 groups: patients using of PCA Morphine IV (group M), patients using of PCA Nalbuphine IV (group N) and patients using of PCA Fentanyl IV (group F).
Outcome measures included; Pain intensity self- assessment by using VAS (visual analogue scale that is graded from 0 -10 where 0 is no pain and 10 is the worst pain imaginable) every 12 hours and during the performing of mouth care for each patient over the first 7 days.
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.
Total opioid consumptions for each patient every 24 hours and the total consumption of the entire 7 days since initiation.
Patient satisfaction at the end of the 7 days. Patient satisfaction score PSS assessed using a linear scale where 0=very satisfied; 10=very dissatisfied.
Serious adverse events. (Nausea and vomiting, pruritus, respiratory depression, urinary retention, sedation, bradycardia, hypotension).
Adverse effects treated appropriately and if a patient developed intolerable side effects (that can be defined as persistent adverse symptoms that are not adequately controlled with using proper treatment), patient resuscitated, relieved and excluded from the study.
Regarding Outcome data; the average patient satisfaction score was (3.89 ± 2.3), with (34.4%) of patients suffered side effects, and (16.7%) had nausea and vomiting,
(5.6%) had respiratory depression, (11.1%) had sedation problems, and (0.9%) had bradycardia.
The 90 mucositis pediatric patients were classified according to the used analgesic drug into 3 independent groups: Fentanyl group (30 patients), Morphine group (30 patients) and Nalbuphine group (30 patients).
Comparative study between the 3 groups revealed that;
• Non-significant difference as regards age and sex of the patients (p > 0.05).
• Non-significant difference as regards all baseline clinical data (p > 0.05).
• Significant increase in patient satisfaction score PSS in Nalbuphine drug group; compared to other drug groups (p = 0.032).
• Highly significant decrease in VAS score (7th day) and total opioid consumption (7th day), in Nalbuphine and Morphine drug groups; compared to Fentanyl control group (p < 0.01 respectively).
• Highly significant decrease in serious side effects (especially respiratory depression and sedation problems), in Nalbuphine and Morphine drug groups; compared to Fentanyl control group (p =
0.0004)