Elective Bilateral Myringotomy Clinical Trial
Official title:
A Prospective Randomized Trial of Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy
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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