Back to resultsLidocaine Gel 2% and Muscle Traction Pain During Squint Surgery in Pediatrics
Primary Purpose
Squint
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lidocaine gel 2%
control group
Sponsored by
About this trial
This is an interventional prevention trial for Squint focused on measuring squint, muscle traction, pain
Eligibility Criteria
Inclusion Criteria:
- age 3 to 12 years
- squint surgery
Exclusion Criteria:
- below 2 years or more than 13
Sites / Locations
- Research Institute of Ophthamology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control
lidocaine group
Arm Description
no lidocaine gel 2% is applied
the lidocaine gel 2% is applied to the operative eye preoperatively
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
oculocardiac reflex occurrence during muscle traction intraoperative
bradycardia at muscle traction during surgery
Full Information
NCT ID
NCT04859062
First Posted
April 8, 2021
Last Updated
September 16, 2022
Sponsor
Research Institute of Ophthalmology, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04859062
Brief Title
Lidocaine Gel 2% and Muscle Traction Pain During Squint Surgery in Pediatrics
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Institute of Ophthalmology, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squint
Keywords
squint, muscle traction, pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 group control and xylocaine gel 2% group
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
no lidocaine gel 2% is applied
Arm Title
lidocaine group
Arm Type
Experimental
Arm Description
the lidocaine gel 2% is applied to the operative eye preoperatively
Intervention Type
Drug
Intervention Name(s)
lidocaine gel 2%
Other Intervention Name(s)
xylocaine gel, topical anesthesia
Intervention Description
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
Other
Intervention Name(s)
control group
Intervention Description
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 Outcome Measure Information:
Title
Postoperative pain after recovery in PACU using FLACC score (Face, Leg, Activity, Cry, Condolence)
Description
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
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
oculocardiac reflex occurrence during muscle traction intraoperative
Description
bradycardia at muscle traction during surgery
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 3 to 12 years
squint surgery
Exclusion Criteria:
below 2 years or more than 13
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abeer salem, MD
Organizational Affiliation
research institute of ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute of Ophthamology
City
Giza
ZIP/Postal Code
12573
Country
Egypt
12. IPD Sharing Statement
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Lidocaine Gel 2% and Muscle Traction Pain During Squint Surgery in Pediatrics
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