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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03480607
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Mansoura University

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.

Condition or disease Intervention/treatment Phase
Cleft Lip Drug: Dexmedetomidine group Drug: Dexamethasone group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Comparative Evaluation of Dexamethasone and Dexmedetomidine as Adjuvants for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block in Infants for Cleft Lip Repair
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : May 10, 2018

Arm Intervention/treatment
Active Comparator: Dexmedetomidine group
Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block
Drug: Dexmedetomidine group
0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine

Active Comparator: Dexamethasone group
Dexamethasone in conjunction with bupivacaine f
Drug: Dexamethasone group
0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone

Primary Outcome Measures :
  1. Postoperative FLACC scale [ Time Frame: for 24 hours after surgery ]
    FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,

  2. Postoperative sedation score [ Time Frame: 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 Outcome Measures :
  1. Heart rate [ Time Frame: For 4 hours after induction ]

  2. Systolic blood pressure [ Time Frame: For 4 hours after induction ]

  3. Postoperative nausea [ Time Frame: 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.

  4. Haematoma formation after surgery [ Time Frame: for 24 hours after surgery ]
    That will be scored as follows; Yes: there is hematoma formation or No: no hematoma formation

  5. Postoperative vomiting [ Time Frame: for 24 hours after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03480607

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Contact: Enas A Abd el Motlb, MD 00201-005-401-236
Contact: Said Emam, MD +201008765995

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Mansoura University Childeren Hospital Recruiting
Mansourah, DK, Egypt, 050
Contact: Enas A Abd el Motlb, MD    00201-005-401-236   
Contact: Said Emam, MD    +201008765995   
Sponsors and Collaborators
Mansoura University
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Study Chair: Enas Abd el Motlb, MD Mansoura University

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Responsible Party: Mansoura University Identifier: NCT03480607    
Other Study ID Numbers: R/17.05.85
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents