Comparing two anesthesia techniques for children's eye surgery
A Comparison Between The Effects Of Peribulbar And Sub-tenon Blocks Combined With General Anesthesia On The Incidence Of Oculocardiac Reflex (OCR) During Pediatric Strabismus Surgery: A Double Blinded Randomised Control Study
This study is testing which of two anesthesia methods works better for children having eye surgery to see if it helps with pain and reduces side effects like vomiting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 6 Years to 13 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06293586 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of peribulbar block and sub-tenon block as adjuncts to general anesthesia in children undergoing strabismus surgery. It will assess their impact on the oculocardiac reflex, postoperative pain management, and incidence of postoperative vomiting. A total of 120 children aged 6 to 13 years, classified as ASA I or II, will be included, while those with specific exclusions such as orbital tumors or allergies to anesthetics will be omitted. The study will involve a thorough pre-anesthetic evaluation and standardized anesthesia induction protocols.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 13 years scheduled for elective strabismus surgery with ASA I or II classification.
Not a fit: Patients with orbital tumors, significant comorbidities, or allergies to local anesthetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve postoperative outcomes and pain management in pediatric strabismus surgery.
How similar studies have performed: Previous studies have shown varying success with similar anesthesia techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants were children (6-13 years), ASA I-II patients, scheduled to undergo strabismus surgery. Exclusion Criteria: * Children with tumors or infections of the orbit, raised intraocular pressure more than 20 mm Hg, axial length more than 28 mm, eye injury, airway abnormalities or who were blind in the eye other than that which was to be operated on were excluded. Other exclusion criteria included patients undergoing revision surgery, known allergy to local anesthetics or non-steroidal antiinflammatory drugs (NSAIDs), steroid therapy, parental refusal to participate and patients with INR more than 1.5 or with platelets less than 100.
Where this trial is running
Cairo
- Cairo University faculty of medicine — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Essam Nossair, Masters
- Email: e.nossair92@gmail.com
- Phone: 0201002014809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.