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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-05-10

Brief Summary

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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.

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Detailed Description

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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

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Cleft Lip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dexmedetomidine group

Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block

Group Type ACTIVE_COMPARATOR

Dexmedetomidine group

Intervention Type DRUG

0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine

Dexamethasone group

Dexamethasone in conjunction with bupivacaine f

Group Type ACTIVE_COMPARATOR

Dexamethasone group

Intervention Type DRUG

0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone

Interventions

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Dexmedetomidine group

0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine

Intervention Type DRUG

Dexamethasone group

0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No