Cleft Lip
Conditions
Brief summary
To assess the efficacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.
Detailed description
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.
Interventions
DRUGDexmedetomidine 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
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
1 Months to 1 Years
Healthy volunteers
No
Inclusion criteria
* American society of anesthesiologist (ASA) physical status I or II
Exclusion criteria
* known allergy to any of drugs used * coagulopathy * any wound or infection related to puncture site * major illness * failure to gain consent of parents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative FLACC scale | for 24 hours after surgery | FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both, |
| Postoperative sedation score | for 4 hours after surgery | 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, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea | for 24 hours after surgery | As nausea can't be detected in this age group; so we will detect only if vomiting occur or not and number of attacks. |
| Heart rate | For 4 hours after induction | (beat/min) |
| Postoperative vomiting | for 24 hours after surgery | — |
| Haematoma formation after surgery | for 24 hours after surgery | That will be scored as follows; Yes: there is hematoma formation or No: no hematoma formation |
| Systolic blood pressure | For 4 hours after induction | (mmHg) |
Countries
Egypt
Outcome results
None listed