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Dexmedetomidine as Adjuvant for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block for Cleft Lip Repair

M

Mansoura University

Status and phase

Completed
Phase 4

Conditions

Cleft Lip

Treatments

Drug: Dexamethasone group
Drug: Dexmedetomidine group

Study type

Interventional

Funder types

Other

Identifiers

NCT03480607
R/17.05.85

Details and patient eligibility

About

To assess the efficacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.

Full 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.

Enrollment

44 patients

Sex

All

Ages

1 month to 1 year old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

44 participants in 2 patient groups

Dexmedetomidine group
Active Comparator group
Description:
Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block
Treatment:
Drug: Dexmedetomidine group
Dexamethasone group
Active Comparator group
Description:
Dexamethasone in conjunction with bupivacaine f
Treatment:
Drug: Dexamethasone group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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