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Unavailable drug in Egypt.
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The investigators aim to compare intranasal dexmedetomidine in a dose of 1ug.kg-1 with sublingual ketorolac in a dose of 1mg.kg-1 on postoperative behaviour in those children undergoing BMT during their PACU stay
Data were analyzed through SPSS (Statistical Package for Social Sciences), Program version 22. Distribution of data was first tested by Shapiro test. Data were presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, an unpaired t-test was used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test was used. Fisher's exact test was used for comparison of categorical data. The P value ≤ 0.05 was considered as the level of statistical significance.
A prior G power analysis was done. Using the results obtained from previous studies (14- 18) and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 60 patients per group was calculated. A drop out 10% of cases is expected, so; 33 cases per group will be required
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intranasal dexmedetomidine | Experimental | this group is planned for intranasal dexmedetomidine |
|
| sublingual ketorolac | Active Comparator | this group is planned for sublingual ketorolac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal dexmedetomidine | Drug | The patient will receive intranasal dexmedetomidine in a dose of 1ug.kg-1 in a volume of 1 ml was dripped into both nostrils using a 1-mL syringe, with the patients in the recumbent position plus 1ml sublingual 0.9% saline |
| Measure | Description | Time Frame |
|---|---|---|
| duration of analgesia | The duration of analgesia,define as the time to the first demand for rescue analgesic | time from administering the study solution till the time for the first rescue analgesic] during first 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score | Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale) . | For 24 hours after surgery |
| Heart rate | for 2 hours after the start of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | DK | 050 | Egypt |
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| sublingual ketorolac | Drug | The patient will receive sublingual ketorolac in a dose of 0.5 mg.kg-1 in a volume of 1 ml and 1 ml intranasal saline 0.9% |
|
| systolic blood pressure | for 2 hours after the start of surgery |
| Number of patients received rescue analgesics | Total number of children who required postoperative pain medication during the 24-h period will be registered | For 24 hours after surgery |
| Degree of sedation | The degree of sedation will be assessed by using Ramsay scale | For 24 hours after surgery |
| Nausea and vomiting | For 24 hours after surgery |