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
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2018
CompletedSeptember 7, 2020
September 1, 2020
9 months
March 7, 2018
September 3, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Postoperative FLACC scale
FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,
for 24 hours after surgery
Postoperative sedation score
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,
for 4 hours after surgery
Secondary Outcomes (5)
Heart rate
For 4 hours after induction
Systolic blood pressure
For 4 hours after induction
Postoperative nausea
for 24 hours after surgery
Haematoma formation after surgery
for 24 hours after surgery
Postoperative vomiting
for 24 hours after surgery
Study Arms (2)
Dexmedetomidine group
ACTIVE COMPARATORDexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block
Dexamethasone group
ACTIVE COMPARATORDexamethasone in conjunction with bupivacaine f
Interventions
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
Eligibility Criteria
You may qualify if:
- American society of anesthesiologist (ASA) physical status I or II
You may not qualify if:
- known allergy to any of drugs used
- coagulopathy
- any wound or infection related to puncture site
- major illness
- failure to gain consent of parents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University Childeren Hospital
Al Mansurah, DK, 050, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Enas Abd el Motlb, MD
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 29, 2018
Study Start
August 1, 2017
Primary Completion
April 30, 2018
Study Completion
May 10, 2018
Last Updated
September 7, 2020
Record last verified: 2020-09