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

NCT04859062 | Completed

• 1 other identifier: 23334
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squint

Keywords

squint; muscle traction; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• oculocardiac reflex occurrence during muscle traction intraoperative

  during surgery

Study Arms (2)

control

PLACEBO COMPARATOR

no lidocaine gel 2% is applied

Other: control group

lidocaine group

EXPERIMENTAL

the lidocaine gel 2% is applied to the operative eye preoperatively

Drug: lidocaine gel 2%

Interventions

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.

Also known as: xylocaine gel, topical anesthesia

lidocaine group

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 .

control

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 3 to 12 years
• squint surgery

You may not qualify if:

• below 2 years or more than 13

Sponsors & Collaborators

• Research Institute of Ophthalmology, Egypt: lead

Study Sites (1)

Research Institute of Ophthamology

Giza, 12573, Egypt

Location

MeSH Terms

Conditions

Strabismus; Pain

Interventions

Anesthesia; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• abeer salem, MD

  research institute of ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 2 group control and xylocaine gel 2% group

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 26, 2021
• Study Start: August 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

EG (1)