- Trials with a EudraCT protocol (14)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (36)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: NO PAEDS INFO Strabismus surgery in children (in German) |
Active substance: ATROPINE |
Study summary document link (including results): NO PAEDS INFO Strabismus surgery in children (in German).pdf |
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Document reference: 47089 |
Study title: Zak-T-A, D-Ambrosio-F-A-Jr. Nutritional nystagmus in infants. Journal of pediatric ophthalmology and strabismus, {J-Pediatr-Ophthalmol-Strabismus}, Jul-Aug 1985, vol. 22, no. 4, p. 140-2, ISSN: 0191-3913.Zak-T-A, D-Ambrosio-F-A-Jr. Nutritional nystagmus in infants. Journal of pediatric ophthalmology and strabismus, {J-Pediatr-Ophthalmol-Strabismus}, Jul-Aug 1985, vol. 22, no. 4, p. 140-2, ISSN: 0191-3913. |
Active substance: BIOTIN |
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Document reference: 22647 |
Study title: Dimenhydrinate decreases vomiting after strabismus surgery in children, Vener, D.F., Anesth. Analg. 1996; 82(4): 728-731Dimenhydrinate decreases vomiting after strabismus surgery in children, Vener, D.F., Anesth. Analg. 1996; 82(4): 728-731 |
Active substance: CAFFEINE AND DIMENHYDRINATE |
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Document reference: 23129 |
Study title: Prophylaxis of postoperative nausea and vomiting (PONV) in children undergoing strabismus surgery. Sevoflurane/N2O plus dimenhydrinate vs. Propofol/remifentanil plus dimenhydrinate, Biallas, R., Anaestesist. 2003; 52(7): 586-595Prophylaxis of postoperative nausea and vomiting (PONV) in children undergoing strabismus surgery. Sevoflurane/N2O plus dimenhydrinate vs. Propofol/remifentanil plus dimenhydrinate, Biallas, R., Anaestesist. 2003; 52(7): 586-595 |
Active substance: CAFFEINE AND DIMENHYDRINATE |
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Document reference: 23103 |
Study title: Rectally administered dimenhydrinate reduces postoperative vomiting in children after strabismus surgery, Schlager, A., Br. J. Anaesth. 2000; 84: 405-406Rectally administered dimenhydrinate reduces postoperative vomiting in children after strabismus surgery, Schlager, A., Br. J. Anaesth. 2000; 84: 405-406 |
Active substance: CAFFEINE AND DIMENHYDRINATE |
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Document reference: 23124 |
Study title: Reduction of postoperative nausea and vomiting by dimenhydrinate suppositories after strabismus surgery in children, Welters, I.D., Anesth. Analg. 2000; 90: 311-314Reduction of postoperative nausea and vomiting by dimenhydrinate suppositories after strabismus surgery in children, Welters, I.D., Anesth. Analg. 2000; 90: 311-314 |
Active substance: CAFFEINE AND DIMENHYDRINATE |
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Document reference: 23131 |
Study title: Postoperative emesis after pediatric strabismus surgery : the effect of dixyrazine compared to droperidol |
Active substance: DIXYRAZINE |
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Document reference: 26277 |
Study title: Dolasetron for the prevention of postoperative vomiting in children undergoing strabismus surgery. Paediatric Anaesthesia. 2003;13:522-526 - Wagner - 2003 - Publication in the GPE report reference Dolasetron mesilate-safety review_Sept96-Jan06_02 (appendix 5) |
Active substance: DOLASETRON |
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Document reference: 26295 |
Study title: Comparison of the efficacy of diclofenac and betamethasone following strabismus surgery. Wright M, Butt Z, McIlwaine G, Fleck B. Br J Ophthalmol. 1997 Apr;81(4):299-301. Comparison of the efficacy of diclofenac and betamethasone following strabismus surgery. Wright M, Butt Z, McIlwaine G, Fleck B. Br J Ophthalmol. 1997 Apr;81(4):299-301. |
Active substance: DICLOPHENAC AND TOBRAMYCIN |
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Document reference: 26090 |
Study title: Wennström B, Reinsfelt B. Rectally administered diclofenac (Voltaren) reduces vomiting compared with opioid (morphine) after strabismus surgery in children. Acta Anaesthesiol Scand. 2002 Apr;46(4):430-4.Wennström B, Reinsfelt B. Rectally administered diclofenac (Voltaren) reduces vomiting compared with opioid (morphine) after strabismus surgery in children. Acta Anaesthesiol Scand. 2002 Apr;46(4):430-4. |
Active substance: DICLOFENAC |
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Document reference: 25974 |
Study title: Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery. Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8.Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery. Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. |
Active substance: CHLORAMPHENICOL_ CHLORAMPHENICOL +CORTISONE ACETATE +ETHACRIDINE LACTATE +ZINC OXIDE / CHLORAMPHENICOL AND MEDROXYPROGESTERONE AND TETRYZOLINE |
Study summary document link (including results): Efficacy of diclofenac vs dexamethasone.pdf |
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Document reference: 23872 |
Study title: A comparison of the pupillary and cardiovascular effects of various mydriatic agents in preterm infants.Sindel BD, Baker MD, Maisels MJ, Weinstein J. J Pediatr Ophthalmol Strabismus. 1986 Nov-Dec;23(6):273-6. A comparison of the pupillary and cardiovascular effects of various mydriatic agents in preterm infants.Sindel BD, Baker MD, Maisels MJ, Weinstein J. J Pediatr Ophthalmol Strabismus. 1986 Nov-Dec;23(6):273-6. |
Active substance: CYCLOPENTOLATE |
Study summary document link (including results): A comparison of the pupillary and cardiovascular effects of .pdf |
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Document reference: 24709 |
Study title: A mydriatic eye-drop combination without systemic effects for premature infants: a prospective double-blind study.Bolt B, Benz B, Koerner F, Bossi E. J Pediatr Ophthalmol Strabismus. 1992 May-Jun;29(3):157-62. A mydriatic eye-drop combination without systemic effects for premature infants: a prospective double-blind study.Bolt B, Benz B, Koerner F, Bossi E. J Pediatr Ophthalmol Strabismus. 1992 May-Jun;29(3):157-62. |
Active substance: CYCLOPENTOLATE |
Study summary document link (including results): A mydriatic eye-drop combination without systemc effects for.pdf |
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Document reference: 24702 |
Study title: Comparison of mydriatic regimens used in screening for retinopathy of prematurity in preterm infants with dark irides.Chew C, Rahman RA, Shafie SM, Mohamad Z. J Pediatr Ophthalmol Strabismus. 2005 May-Jun;42(3):166-73. Comparison of mydriatic regimens used in screening for retinopathy of prematurity in preterm infants with dark irides.Chew C, Rahman RA, Shafie SM, Mohamad Z. J Pediatr Ophthalmol Strabismus. 2005 May-Jun;42(3):166-73. |
Active substance: CYCLOPENTOLATE |
Study summary document link (including results): Comparison of mydriatic regimens used in screening for retin.pdf |
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Document reference: 24698 |
Study title: Systemic response to mydriatic eyedrops in neonates: mydriatics in neonates.Caputo AR, Schnitzer RE. J Pediatr Ophthalmol Strabismus. 1978 Mar-Apr;15(2):109-22.Systemic response to mydriatic eyedrops in neonates: mydriatics in neonates.Caputo AR, Schnitzer RE. J Pediatr Ophthalmol Strabismus. 1978 Mar-Apr;15(2):109-22. |
Active substance: CYCLOPENTOLATE |
Study summary document link (including results): Systemic response to mydriatic eyedrops in neonates.pdf |
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Document reference: 24712 |
Study title: Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery.Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery.Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. |
Active substance: DEXAMETHASONE NEOMYCIN POLYMYXIN B |
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Document reference: 25757 |
Study title: Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery.Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. |
Active substance: DEXAMETHASONE_OR_DEXAMETHASONE AND CHLORAMPHENICOL |
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Document reference: 25768 |
Study title: Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery.Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. 4. Postoperative miotics for patients with infantile esotropia.Spierer A, Zeeli T. Ophthalmic Surg Lasers. 1997 Dec;28(12):1002-5. Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery.Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. 4. Postoperative miotics for patients with infantile esotropia.Spierer A, Zeeli T. Ophthalmic Surg Lasers. 1997 Dec;28(12):1002-5. |
Active substance: DEXAMETHASONE AND GENTAMYCIN AND TETRYZOLINE |
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Document reference: 25736 |
Study title: Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery.Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery.Snir M, Axer-Siegel R, Friling R, Weinberger D. Ophthalmology. 2000 Oct;107(10):1884-8. |
Active substance: DEXAMETHASONE AND NEOMYCIN |
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Document reference: 25743 |
Study title: Diclofenac vs oxybuprocaine eyedrops for analgesia in paediatric strabismus surgery. Morton NS, Benham SW, Lawson RA, McNicol LR. Paediatr Anaesth. 1997;7(3):221-6. |
Active substance: FLUORESCEIN AND OXYBUPRICAINE |
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Document reference: 28249 |