Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04859062
Enrollment
40
Registered
2021-04-26
Start date
2021-08-01
Completion date
2022-04-01
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squint

Keywords

squint, muscle traction, pain

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.

Interventions

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.

OTHERcontrol group

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 .

Sponsors

Research Institute of Ophthalmology, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

2 group control and xylocaine gel 2% group

Eligibility

Sex/Gender
ALL
Age
2 Years to 13 Years
Healthy volunteers
Yes

Inclusion criteria

* age 3 to 12 years * squint surgery

Exclusion criteria

* below 2 years or more than 13

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain after recovery in PACU using FLACC score (Face, Leg, Activity, Cry, Condolence)during surgeryFLACC (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

MeasureTime frameDescription
oculocardiac reflex occurrence during muscle traction intraoperativeduring surgerybradycardia at muscle traction during surgery

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026