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Lidocaine Gel 2% and Muscle Traction Pain During Squint Surgery in Pediatrics

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.
 
ClinicalTrials.gov Identifier: NCT04859062
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Abeer Samir Salem, Research Institute of Ophthalmology, Egypt

Study Description
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Brief Summary:
Assessing the efficacy of lidocaine gel 2% application 10 minutes before surgery on post operative pain and the use of analgesics postoperatively

Condition or disease Intervention/treatment
Squint Other: lidocaine gel 2%

Detailed Description:

After inhalational induction of anesthesia and applying the pulse oximeter to the patient's finger but and before cannulating or managing the patient's airway lidocaine gel 2% is efficiently applied to the surgical eye (to give more time for the gel to act without delaying the surgery) then cannulation and laryngeal mask inserted to maintain ventilation properly.

Applying lidocaine gel 2% should be filling the upper and lower 10 minute fornices before disinfecting the eye and starting the surgery

The primary outcome is assessing postoperative pain and need for postoperative systemic analgesia The secondary outcome is to monitor the oculocardiac reflex intraoperatively and the need for intraoperative atropine.

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Applying Xylocaine Gel 2% to the Eye Preoperatively in Pediatrics Undergoing Squint Surgeries on Oculocardiac Reflex Intraoperatively and Postoperative Pain and Agitation: Cohort Study
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: lidocaine gel 2%
    assessing its efficacy in decreasing muscle traction pain

Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pain after recovery in PACU using FLACC score (Face, Leg, Activity, Cry, Condolence) [ Time Frame: jan 2021 to july 2021 ]
    FLACC (Face, legs, activity, cry, condolence): each parameter will take a score from 0 to 2 and the total of the 5 parameters is a score of pain ; 0 is for no pain and 10 is maximal pain


Secondary Outcome Measures :
  1. oculocardiac reflex occurrence during muscle traction intraoperative [ Time Frame: jan 2021 to july 2021 ]
    bradycardia at muscle traction during surgery


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
pediatrics undergoing squint surgeries
Criteria

Inclusion Criteria:

  • age 3 to 12 years
  • squint surgery

Exclusion Criteria:

  • below 2 years or more than 13
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04859062


Contacts
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Contact: abeer salem, MD 01125666006 ext 002 Asalem@rio.edu.eg
Contact: omnia aboelazem, MD 0100624143 ext 002 Dr.omnia.aboelazm@cu.edu.eg

Locations
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Egypt
Research Institute of Ophthamology Recruiting
Giza, Egypt, 12573
Contact: abeer 00 salem, md    01125666006 ext 002    Asalem@rio.edu.eg   
Sponsors and Collaborators
Research Institute of Ophthalmology, Egypt
Investigators
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Principal Investigator: abeer salem, MD research institute of ophthalmology
More Information
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Responsible Party: Abeer Samir Salem, Researcher, Research Institute of Ophthalmology, Egypt
ClinicalTrials.gov Identifier: NCT04859062    
Other Study ID Numbers: 23334
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abeer Samir Salem, Research Institute of Ophthalmology, Egypt:
squint
muscle traction
pain
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action