A Phase 4 interventional study of Dexmedetomidine group and Dexamethasone group in Cleft Lip, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 1 Month to 1 Year. Per ClinicalTrials.gov, last updated 2020-09-07.
Sponsored by Mansoura University · Phase 4, Interventional, and Supportive care
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.
Exclusion Criteria:
Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block
Drug: Dexmedetomidine group
Dexamethasone in conjunction with bupivacaine f
Drug: Dexamethasone group
0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine
0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone
Postoperative FLACC scale
FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,
Time frame: for 24 hours after surgery
Postoperative sedation score
The degree of sedation will be assessed by using a three point sedation scale based on eye opening: - Alert with spontaneous eye opening 0, - Drowsy with eyes only opening in response to speech 1, - Sedated with eyes opening in response to physical stimulation 2,
Time frame: for 4 hours after surgery
Heart rate
(beat/min)
Time frame: For 4 hours after induction
Systolic blood pressure
(mmHg)
Time frame: For 4 hours after induction
Postoperative nausea
As nausea can't be detected in this age group; so we will detect only if vomiting occur or not and number of attacks.
Time frame: for 24 hours after surgery
Haematoma formation after surgery
That will be scored as follows; Yes: there is hematoma formation or No: no hematoma formation
Time frame: for 24 hours after surgery
Postoperative vomiting
Time frame: for 24 hours after surgery
Plan to share: Undecided
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Mansoura University