Cleft Lip Clinical Trial
Official title:
Comparative Evaluation of Dexamethasone and Dexmedetomidine as Adjuvants for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block in Infants for Cleft Lip Repair
To assess the efficacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.
Regarding patient registry; A prior G power analysis was done. Using the results obtained
from previous studies and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the
study 80 %), a sample size of 20 patients per group was calculated. A drop out 10% of cases
is expected, so; 22 cases per group will be required.
Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social
Sciences). Program version 22. Distribution of data will be first tested by Shapiro test.
Data will be presented as mean and standard deviation (SD), median and range or numbers and
percentages. For normally distributed data, unpaired t test will be used to compare between
mean values of both groups. For pain and sedation scores, Mann Whitney U test will be used.
Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will
be considered as the level of statistical significance.
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