perioperative analgesia
Conditions
Interventions
Trade Name: Novain 0.4%
Product Name: Novain 0.4%
Pharmaceutical Form: Eye drops
INN or Proposed INN: Novain 0.4%
Other descriptive name: OXYBUPROCAINE HYDROCHLORIDE
Concentration unit: mg/ml milligra
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this study we want to evaluate the role of additional topical Oxybuprocainhydrochlorid (Novain 0.4%) versus Placebo lubrication eye drops (Oculotect®) for perioperative analgesia in pediatric surgery with regard to intra- and postoperative pain management. ;Secondary Objective: •Anesthesia variables Durations Hemodynamic monitoring Oxygenation Intraoperative pain score Postoperative pain assessment •Ophthalmologic variables Surgical variables Intra- and postoperative complications Functional and morphologic results ;Primary end point(s): Amount of intraoperative analgesia with intravenous fentanyl (1 µg/kg; 0.2 mL/kg of 5 µg/kg) and the postoperative analgesia;Timepoint(s) of evaluation of this end point: day of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Anesthesia variables o Durations: total anesthesia time, time for intubation and extubation, time at the recovery room o Hemodynamic monitoring: heart rate, pulse, blood pressure (systolic and diastolic) o Oxygenation: intraoperative and postoperative in the recovery room o Intraoperative pain score: salivation, tearing, Bell phenomenon o Postoperative: nausea, vomiting, headache, sore throat; time to drink; time to eat; discharge same/next day • Ophthalmologic variables o Surgical variables: duration of surgery, type of surgery o Safety o Intraoperative complications: Iris bleeding, iris prolapse, hypotony, expulsive bleeding, posterior capsule rupture, vitreous loss, globe perforation o Postoperative complications: Retinal detachment, endophthalmitis, visual axis obscuration (VAO), nystagmus, strabismus, amblyopia o Functional and morphologic results • Demographic information o Age, gender ;Timepoint(s) of evaluation of this end point: surgery day and postoperative follow-up visits: one day, one week, one, three and six months after surgery | — |
Countries
Austria
Contacts
Public ContactMUW
Medical University of Vienna
Outcome results
None listed