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Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery. (IFONB)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02514980
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Hala Saad Abdel-Ghaffar, Assiut University

Tracking Information
First Submitted Date  ICMJE August 1, 2015
First Posted Date  ICMJE August 4, 2015
Last Update Posted Date January 31, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
postoperative analgesic consumption [ Time Frame: 24 hours postoperative ]
the total consumption of analgesics in the first 24h postoperative
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
  • Postoperative The Face, Legs, Activity, Cry, Consolability ( FLACC) pain score [ Time Frame: 24 h postoperative. ]
    FLACC pain score will be recorded on arrival to the recovery room (0) and at 1, 2, 3, 4, 8, 12, and 24 hours postoperative.
  • Parent satisfaction score [ Time Frame: 24 h postoperative ]
    The parents will be asked to evaluate their satisfaction regarding pain control at the end of 24 hours over a score of 4 points (1=bad, 2=moderate, 3=good, 4=excellent).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery.
Official Title  ICMJE Infra-orbital Nerve Block for Post Operative Analgesia in Young Children Undergoing Pediatric Cleft Lip Surgery.
Brief Summary this study will be undertaken to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.
Detailed Description

Oro-facial clefts are the most prevalent craniofacial birth defects and the second most common birth anomaly, second only to clubfoot [Strong & Buckmiller 2001]. Cleft lip surgery is associated with appreciable postoperative pain in children Alleviation of postoperative pain is important in these patients. The fear of respiratory depression using opioids has renewed the interest in regional anesthesia to provide safe and effective postoperative analgesia. Infra-orbital nerve block has been advocated as a suitable local analgesic technique for cleft lip surgery and superficial surgery on the mid face [Morton 2004, Takmaz et al. 2009, Rajesh et al. 2011, Jindal et al. 2011].The infra-orbital nerve supplies the upper lip, lower eyelid, and adjacent skin of the cheek and nose. Unilateral or bilateral infra-orbital nerve block has been performed with a very high success rate.

The investigators designed this study to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Bupivacaine
    Infraorbital nerve block using bupivacaine 0.25% on each side.
    Other Name: bucaine
  • Drug: Ketamine
    Infraorbital nerve block using 0.5mg/kg ketamine on each side.
    Other Name: Katalar
Study Arms  ICMJE
  • Active Comparator: Bupivacaine group
    Infraorbital nerve block using bupivacaine 0.25% on each side.
    Intervention: Drug: Bupivacaine
  • Active Comparator: Bupivacaine-Ketamine group.
    Infraorbital nerve block using bupivacaine 0.25% combined with 0.5mg/kg ketamine on each side.
    Interventions:
    • Drug: Bupivacaine
    • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2016)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2015)
40
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

(ASA) physical status I and II aged less than 2 years undergoing elective cleft lip repair (with or without cleft palate) under general anesthesia.

Exclusion Criteria:

Patients with local infection at the site of injection of block, history suggestive of drug allergy, any systemic disease that compromises the cardiovascular, respiratory or neurological function, other congenital anomaly, history of upper or lower airway disease, coagulation disorders, and children with history of sleep apnea and in whom postoperative ventilation may be required will be excluded from the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02514980
Other Study ID Numbers  ICMJE IRB00008718/ ref. no.103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This is a single center study with no plan to share data
Responsible Party Hala Saad Abdel-Ghaffar, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hala S Abdel-Ghaffar, MD Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
PRS Account Assiut University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP