Trials / Completed
CompletedNCT03480607
Dexmedetomidine as Adjuvant for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block for Cleft Lip Repair
Comparative Evaluation of Dexamethasone and Dexmedetomidine as Adjuvants for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block in Infants for Cleft Lip Repair
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Mansoura University · Academic / Other
- Sex
- All
- Age
- 1 Month – 1 Year
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexmedetomidine group | 0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine |
| DRUG | Dexamethasone group | 0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone |
Timeline
- Start date
- 2017-08-01
- Primary completion
- 2018-04-30
- Completion
- 2018-05-10
- First posted
- 2018-03-29
- Last updated
- 2020-09-07
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT03480607. Inclusion in this directory is not an endorsement.