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

NCT ID: NCT04859062

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-04-01

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.

Conditions

Squint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

control

no lidocaine gel 2% is applied

Group Type: PLACEBO_COMPARATOR

control group

Intervention Type: 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 .

lidocaine group

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

Group Type: EXPERIMENTAL

lidocaine gel 2%

Intervention Type: 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.

Interventions

lidocaine gel 2%

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.

Intervention Type: DRUG

control 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 .

Intervention Type: OTHER

Other Intervention Names

xylocaine gel, topical anesthesia

Eligibility Criteria

Inclusion Criteria

• age 3 to 12 years
• squint surgery

Exclusion Criteria

• below 2 years or more than 13

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Institute of Ophthalmology, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Abeer Samir Salem

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

abeer salem, MD

Role: PRINCIPAL_INVESTIGATOR

research institute of ophthalmology

Locations

Research Institute of Ophthamology

Giza, , Egypt

Countries

Egypt

Other Identifiers

23334

Identifier Type: -

Identifier Source: org_study_id