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

Ketamine

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.

Intervention / Treatment

  • Bupivacaine (DRUG)
    Infraorbital nerve block using bupivacaine 0.25% on each side.
  • Ketamine (DRUG)
    Infraorbital nerve block using 0.5mg/kg ketamine on each side.

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Months to 6 Years
    Enrollment: 30 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2015
    Primary Completion: Aug 01, 2016 ACTUAL
    Completion Date: Aug 01, 2016 ACTUAL
    Study First Posted: Aug 04, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 28, 2017

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    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.

    Participant Groups

    • Infraorbital nerve block using bupivacaine 0.25% on each side.

    • Infraorbital nerve block using bupivacaine 0.25% combined with 0.5mg/kg ketamine on each side.

    Eligibility Criteria

    Sex: All
    Maximum Age: 6
    Age Groups: Child
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • the total consumption of analgesics in the first 24h postoperative

    Secondary Outcomes

    • 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.

    • 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).

    More Details

    NCT Number: NCT02514980
    Acronym: IFONB
    Other IDs: IRB00008718/ ref. no.103
    Study URL: https://clinicaltrials.gov/study/NCT02514980
    Last updated: Sep 29, 2023