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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Squint

Intervention / Treatment
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* Drug: lidocaine gel 2%
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 3 to 12 years squint surgery Exclusion Criteria: below 2 years or more than 13

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 group control and xylocaine gel 2% group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>no lidocaine gel 2% is applied | Other: control group<br>* In the operation room, we started inhalational induction of anesthesia with sevoflurane till the patient is deeply anesthetized. In control group, we didn't apply lidocaine gel 2% to the operative eye .<br>|
| Experimental: lidocaine group<br>the lidocaine gel 2% is applied to the operative eye preoperatively | Drug: lidocaine gel 2%<br>* assessing its efficacy in decreasing muscle traction pain,In the operation room, we started inhalational induction of anesthesia with sevoflurane till the patient is deeply anesthetized. In the experimental group, we applied lidocaine gel 2% abundantly below both eyelids of the surgical eye for at least 3 minutes before the surgical incision, while nothing was applied to patients in the control group.<br>* Other names: xylocaine gel, topical anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain after recovery in PACU using FLACC score (Face, Leg, Activity, Cry, Condolence) | 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 | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oculocardiac reflex occurrence during muscle traction intraoperative | bradycardia at muscle traction during surgery | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squint, muscle traction, pain