- Trials with a EudraCT protocol (140)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (35)
Query did not match any clinical trials.
| 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: Milnes-Intravenous sedation in pediatric dentistry using midazolam, nalbuphine and droperidol. Milnes-Pediatr Dent. 2000; 22(2):113-9.Milnes-Intravenous sedation in pediatric dentistry using midazolam, nalbuphine and droperidol. Milnes-Pediatr Dent. 2000; 22(2):113-9. |
| Active substance: DROPERIDOLE |
| Study summary document link (including results): |
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| Document reference: 26351 |
| Study title: Comparative study of midazolam and valium in ketamine/air anesthesia for ambulatory urological procedures in children. |
| Active substance: DIAZEPAM |
| Study summary document link (including results): |
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| Document reference: 25933 |
| Study title: Lahat E, Goldman M, Barr J, Bistritzer T, Berkovitch M. Comparison of intranasal midazolam with intravenous diazepam for treating febrile seizures in children: prospective randomised study. BMJ. 2000 Jul 8;321(7253):83-6.Lahat E, Goldman M, Barr J, Bistritzer T, Berkovitch M. Comparison of intranasal midazolam with intravenous diazepam for treating febrile seizures in children: prospective randomised study. BMJ. 2000 Jul 8;321(7253):83-6. |
| Active substance: DIAZEPAM |
| Study summary document link (including results): |
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| Document reference: 25946 |
| Study title: Mahmoudian T, Zadeh MM. Comparison of intranasal midazolam with intravenous diazepam for treating acute seizures in children. Epilepsy Behav. 2004 Apr;5(2):253-5.Mahmoudian T, Zadeh MM. Comparison of intranasal midazolam with intravenous diazepam for treating acute seizures in children. Epilepsy Behav. 2004 Apr;5(2):253-5. |
| Active substance: DIAZEPAM |
| Study summary document link (including results): |
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| Document reference: 25942 |
| Study title: Martinez JL, Sutters KA, Waite S, Davis J, Medina E, Montano N, Merzel D, Marquez C. A comparison of oral diazepam versus midazolam, administered with intravenous meperidine, as premedication to sedation for pediatric endoscopy. J Pediatr Gastroenterol Nutr. 2002 Jul;35(1):51-8. Martinez JL, Sutters KA, Waite S, Davis J, Medina E, Montano N, Merzel D, Marquez C. A comparison of oral diazepam versus midazolam, administered with intravenous meperidine, as premedication to sedation for pediatric endoscopy. J Pediatr Gastroenterol Nutr. 2002 Jul;35(1):51-8. |
| Active substance: DIAZEPAM |
| Study summary document link (including results): |
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| Document reference: 25944 |
| Study title: Shah I, Deshmukh CT. Intramuscular midazolam vs intravenous diazepam for acute seizures Indian J Pediatr. 2005 Aug;72(8):667-70.Shah I, Deshmukh CT. Intramuscular midazolam vs intravenous diazepam for acute seizures Indian J Pediatr. 2005 Aug;72(8):667-70. |
| Active substance: DIAZEPAM |
| Study summary document link (including results): |
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| Document reference: 25939 |
| Study title: Safety of intravenous midazolam and fentanyl for pediatric GI endoscopy: prospective study of 1578 endoscopies. Mamula, P., et al., Gastrointest Endosc, 2007. 65(2): p. 203-10. |
| Active substance: FENTANYL |
| Study summary document link (including results): |
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| Document reference: 27180 |
| Study title: A comparison of oral transmucosal fentanyl and oral midazolam for premedication in children. Howell TK, Smith S, Rushman SC, Walker RW, Radivan F. Anaesthesia. 2002 Aug;57(8):798-805. |
| Active substance: FENTANYL |
| Study summary document link (including results): |
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| Document reference: 27125 |
| Study title: A randomized, clinical trial of oral midazolam plus placebo versus oral midazolam plus oral transmucosal fentanyl for sedation during laceration repair; Pediatrics,2002, 109(5): 894-897 |
| Active substance: FENTANYL |
| Study summary document link (including results): |
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| Document reference: 27130 |
| Study title: Comparison of chloral hydrate, meperidine, and hydroxyzine to midazolam regimens for oral sedation of pediatric dental patients. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE06B2013.pdf |
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| Document reference: 29239 |
| Study title: Comparison of oral midazolam with and without hydroxyzine in the sedation of pediatric dental patients. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE05B1415.pdf |
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| Document reference: 29339 |
| Study title: Effectiveness of midazolam/hydroxyzine compared to chloral hydrate/hydroxyzine in sedating pedodontic patients |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE02H2305.pdf |
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| Document reference: 29276 |
| Study title: The effectiveness of midazolam and hydroxyzine as sedative agents for young pediatric dental patients. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE97G1128.pdf |
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| Document reference: 29338 |
| Study title: The efficacy of midazolam-famotidine suppository for premedication in children |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPZ96D2915.pdf |
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| Document reference: 29274 |
| Study title: A prospective study of 2 sedation regimens in children: chloral hydrate, meperidine, and hydroxyzine versus midazolam, meperidine, and hydroxyzine. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE07C2107.pdf |
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| Document reference: 29340 |
| Study title: A randomized double-blind trial of chloral hydrate/ hydroxyzine versus midazolam/acetaminophen in the sedation of pediatric dental outpatients. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE97G2901.pdf |
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| Document reference: 29321 |
| Study title: A randomized, controlled, crossover trial of oral midazolam and hydroxyzine for pediatric dental sedation. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE04B1014.pdf |
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| Document reference: 29244 |
| Study title: A retrospective study of chloral hydrate, meperidine, hydroxyzine, and midazolam regimens used to sedate children for dental care. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE01A1503.pdf |
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| Document reference: 29366 |
| Study title: Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study. |
| Active substance: HYDROXYZINE |
| Study summary document link (including results): ADPE96L1314.pdf |
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| Document reference: 29285 |
| Study title: PA Averley, NM Girdler, S Bond, N Steen, J Steele. A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide⁄sevoflurane. Anaesthesia, 2004, 59, pages 844–852 PA Averley, NM Girdler, S Bond, N Steen, J Steele. A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide⁄sevoflurane. Anaesthesia, 2004, 59, pages 844–852 |
| Active substance: NITROUS OXIDE |
| Study summary document link (including results): |
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| Document reference: 32669 |
