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NCT Number: NCT04859062

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

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

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Key information

Conditions

Squint Cranial Nerve Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Ocular Motility Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Strabismus

Age range

2 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Ophthamology

Giza, 12573, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 3 to 12 years
  • squint surgery

Exclusion criteria

  • below 2 years or more than 13

Treatment and study plan

lidocaine gel 2%

Drug

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.

Other names: xylocaine gel, topical anesthesia

Control Group

Other

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 .

Primary outcomes

  1. Postoperative pain after recovery in PACU using FLACC score (Face, Leg, Activity, Cry, Condolence)

    Time frame: during surgery

    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 outcomes

  1. oculocardiac reflex occurrence during muscle traction intraoperative

    Time frame: during surgery

    bradycardia at muscle traction during surgery

Sponsors and collaborators

Lead sponsor

Research Institute of Ophthalmology, Egypt

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2021
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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