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

Not Applicable

Completed

• Conditions: Squint
• Interventions: Drug: lidocaine gel 2%; Other: control group

• Registration Number: NCT04859062
• Lead Sponsor: Research Institute of Ophthalmology, Egypt

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-26
• Study Start: 2021-08-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age 3 to 12 years
• squint surgery

Exclusion Criteria

• below 2 years or more than 13

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine group	lidocaine gel 2%	the lidocaine gel 2% is applied to the operative eye preoperatively
control	control group	no lidocaine gel 2% is applied

Primary Outcome Measures

Name	Time	Method
Postoperative pain after recovery in PACU using FLACC score (Face, Leg, Activity, Cry, Condolence)	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 Outcome Measures

Name	Time	Method
oculocardiac reflex occurrence during muscle traction intraoperative	during surgery	bradycardia at muscle traction during surgery

Trial Locations

Locations (1)

Research Institute of Ophthamology; 🇪🇬 Giza, Egypt