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Perioperative Pain Management for Cleft Lip in Children

Primary Purpose

Perioperative Complication Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bupivacain
i.v. analgesia
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perioperative Complication Pain

Eligibility Criteria

6 Months - 3 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • good physical condition.
  • Age 6 months to 3 years.
  • Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both .

Exclusion Criteria:

  • Children posted for combined procedures like congenital heart correction with palatoplasty .
  • Parents refusal .
  • Bleeding disorders( platelets count < 100.000 , international ratio >1.5).
  • Skin lesions or wounds at site of needle insertion .
  • Co-morbidities as congenital heart disease , lung pathology or central nervous system
  • Known hypersensitivity to local anesthetics or opioids .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    intravenous analgesia

    infraorbital nerve block

    Arm Description

    Outcomes

    Primary Outcome Measures

    Postoperative opioid consumption
    Total rescue doses of morphine

    Secondary Outcome Measures

    Full Information

    First Posted
    October 21, 2020
    Last Updated
    November 3, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04614259
    Brief Title
    Perioperative Pain Management for Cleft Lip in Children
    Official Title
    Perioperative Pain Management for Cleft Lip Repair in Children, Bilateral Infraorbital Nerve Block Versus Conventional Methods( Combined IV Fentanyl With Peri Incisional Infiltration). A Randomized Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 15, 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perioperative Complication Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intravenous analgesia
    Arm Type
    Experimental
    Arm Title
    infraorbital nerve block
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacain
    Intervention Description
    The infraorbital foramen was located at the floor of the orbital rim at about the level of the pupil,The upper lip was folded back and a finger is placed externally at the level of the infraorbital foramen to prevent the needle from the cephalad insertion in the globe of the eye. A 27-gauge needle was bent about 70 degree to ease the insertion through the buccal mucosa over the maxillary process, towards the infraorbital foramen. After careful aspiration the local anesthetic was injected (injection of 3 ml 0.25% bupivacaine in 1:200.000 adrenaline ,1.5 ml on each side). [104] Pressure was needed to be applied for one minute to the area as there is loose adventitious tissue that can lead to swelling and ecchymosis
    Intervention Type
    Combination Product
    Intervention Name(s)
    i.v. analgesia
    Intervention Description
    Using inhalational induction with sevoflurane as tolerated , atracurium 0.5mg/kg to facilitate endotracheal intubation and fentanyl 1 mcg/kg ,Mechanical ventilation was adjusted to maintain 30 to 35 mmHg end-tidal carbon dioxide, anesthesia was maintained with 1.5 % isoflurane and atracurium (0.1 mg/kg every 30 minutes) ,all patients were received intraoperative diclofenac sodium 0.5 mg/kg intramuscular . Blood pressure and heart rate were measured 5 minutes after endotracheal intubation and every 15 minutes till recovery from the anesthesia then every 15 min in the postoperative care unite for 30 minutes
    Primary Outcome Measure Information:
    Title
    Postoperative opioid consumption
    Description
    Total rescue doses of morphine
    Time Frame
    24 huors

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: good physical condition. Age 6 months to 3 years. Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both . Exclusion Criteria: Children posted for combined procedures like congenital heart correction with palatoplasty . Parents refusal . Bleeding disorders( platelets count < 100.000 , international ratio >1.5). Skin lesions or wounds at site of needle insertion . Co-morbidities as congenital heart disease , lung pathology or central nervous system Known hypersensitivity to local anesthetics or opioids .

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Do not share
    Citations:
    PubMed Identifier
    460932
    Citation
    Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.
    Results Reference
    background
    PubMed Identifier
    16118385
    Citation
    Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.
    Results Reference
    background
    Citation
    Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
    Results Reference
    background
    Citation
    Doyle E, Hudson I. Anesthesia for primary repair of cleft lip and cleft palate: a review of 244 procedures. Paediatr Anaesth 1992; 2: 139-145.
    Results Reference
    background
    PubMed Identifier
    12358652
    Citation
    Takemura H, Yasumoto K, Toi T, Hosoyamada A. Correlation of cleft type with incidence of perioperative respiratory complications in infants with cleft lip and palate. Paediatr Anaesth. 2002 Sep;12(7):585-8. doi: 10.1046/j.1460-9592.2002.00906.x.
    Results Reference
    background

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    Perioperative Pain Management for Cleft Lip in Children

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