Pain management in children undergoing eye surgery

Phase 1

• Conditions: perioperative analgesia; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-004501-27-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-15
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

•Written informed consent to participate in the study by the parental guardian
•Zero to three years of age
•Uni- and bilateral cataract
•Strabismus convergens or divergens
•Scheduled for ophthalmic surgery

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•History of secondary cataract (inflammatory, uveitic)
•History of connatal cataract associated with Rieger syndrome, Rieger-Axenfeld syndrome, Peters anomaly
•History of ectoia lentis associated with Marfan syndrome, homocystinuria or Ehlers-Danlos syndrom
•History of penetrating or perforating eye trauma
•Previous surgery due to glaucoma, retinal detachment
•Active intraocular inflammation (grade trace or above) in the study eye, like infectious conjunctivitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified