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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Active Comparator | Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block |
|
| Dexamethasone group | Active Comparator | Dexamethasone in conjunction with bupivacaine f |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine group | Drug | 0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative FLACC scale | FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both, | 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, | for 4 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | (beat/min) | For 4 hours after induction |
| Systolic blood pressure | (mmHg) | For 4 hours after induction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enas Abd el Motlb, MD | Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Childeren Hospital | Al Mansurah | DK | 050 | Egypt |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| Dexamethasone group | Drug | 0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone |
|
| 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. | 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 | for 24 hours after surgery |
| Postoperative vomiting | for 24 hours after surgery |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |