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Clinical trials for FLACC scale

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    23 result(s) found for: FLACC scale. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2010-021499-27 Sponsor Protocol Number: Kreussler-Dynexan® Mundgel-0410 Start Date*: 2010-09-13
    Sponsor Name:Chemische Fabrik Kreussler & Co. GmbH
    Full Title: A Prospective, Randomized, Multi-centre, Placebo-controlled, Double blind, Comparative Study To Evaluate the Efficacy and Safety of Dynexan® Mundgel in Subjects with Acute Teething Pain
    Medical condition: Teething in babies which can lead to symptoms like irritability, rash, and severe pain.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10052001 Teething pain LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-000057-40 Sponsor Protocol Number: dex_vs_ket Start Date*: 2017-06-12
    Sponsor Name:Karolinska University Hospital
    Full Title: A prospective randomized double-blind study Intranasal dexmedetomidine versus intranasal S-ketamine for children age 1 – 3 years for procedural sedation and analgesia in pediatric emergency departm...
    Medical condition: sedation for emergency procedures
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001297-41 Sponsor Protocol Number: OY072017 Start Date*: 2018-02-13
    Sponsor Name:Oulu university hospital
    Full Title: Intranasal dexmedetomidine sedation and analgesia during minor procedures in the pediatric emergency room : Randomized double-blinded clinical trial
    Medical condition: Patients of the pediatric emergency room at Oulu University Hospital with any medical condition requiring a minor painful procedure such as i.v. cannulation or lumbar puncture are asked to join our...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004851-30 Sponsor Protocol Number: GABA-1 Start Date*: 2016-08-01
    Sponsor Name:PHARM – Pharmaceutical Research Management srl
    Full Title: Randomized, double-blind, double-dummy, active controlled, multicentre, non-inferiority phase-III study to compare the pharmacokinetic, efficacy and safety of gabapentin liquid formulation to trama...
    Medical condition: Chronic pain of neuropathic or mixed origin
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004852 10054095 Neuropathic pain LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) DE (Completed) FR (Ongoing) GR (Prematurely Ended) GB (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004897-40 Sponsor Protocol Number: GABA-2 Start Date*: Information not available in EudraCT
    Sponsor Name:PHARM – Pharmaceutical Research Management srl
    Full Title: Randomized, double-blind, placebo controlled, multi-centre, superiority phase II study to evaluate the safety, pharmacokinetic, efficacy of gabapentin liquid formulation as add-on to morphine in ch...
    Medical condition: Chronic pain of neuropathic or mixed origin
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004852 10054095 Neuropathic pain LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Ongoing) NL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-003773-17 Sponsor Protocol Number: dex_version1 Start Date*: 2017-06-12
    Sponsor Name:Karolinska University Hospital
    Full Title: A prospective randomized open label study Intranasal dexmedetomidine versus inhaled nitrous oxide for children age 3 – 15 years for procedural sedation and analgesia in pediatric emergency departme...
    Medical condition: sedation for emergency procedures
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-004497-33 Sponsor Protocol Number: Protocol_Dysport_v3__13.12.2017 Start Date*: 2018-03-06
    Sponsor Name:Copenhagen University Hospital at Hvidovre
    Full Title: Measuring effects on pain and quality of life after Dysport® injection in children with cerebral palsy
    Medical condition: Muscle pain in the extremities due to spasticity in children with cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10028322 Muscle pain LLT
    20.0 100000004852 10041418 Spasticity muscle LLT
    20.1 100000004850 10021745 Infantile cerebral palsy, unspecified LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-005215-42 Sponsor Protocol Number: KloMid02 Start Date*: 2013-04-12
    Sponsor Name:Department of Anesthesiology and Intensive Care Medicine
    Full Title: Children's mood/anxiety, pain, nausea and behavioral changes after premedication with Clonidine versus Midazolam in ENT day surgery.
    Medical condition: Preanesthetic Medication at ear-nose-throat surgery
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002066-32 Sponsor Protocol Number: BEB-13 Start Date*: 2017-11-10
    Sponsor Name:Amryt Research Limited
    Full Title: Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa
    Medical condition: Inherited Epidermolysis Bullosa
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) AT (Completed) DE (Completed) ES (Ongoing) GR (Completed) HU (Completed) CZ (Completed) BE (Completed) DK (Completed) IT (Completed) HR (Completed) FR (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-002803-81 Sponsor Protocol Number: TREX Start Date*: 2020-04-03
    Sponsor Name:IRCCS ISTITUTO GIANNINA GASLINI
    Full Title: Neurodevelopmental outcome after standard dose sevoflurane versus low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia in young children
    Medical condition: Children under the age of 2 years having surgery lasting at least 2 hours
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10018060 General anaesthesia PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021955-14 Sponsor Protocol Number: BUP3030 Start Date*: 2011-10-17
    Sponsor Name:Purdue Pharma L.P.
    Full Title: A Multicenter, Inpatient, Open-label Study to Characterize the Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Aged from Birth to 6 Years of Age...
    Medical condition: Acute moderate to severe pain requiring opioids for at least 24 hours in postoperative and prolonged endotracheal intubated patients
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10002182 Analgesia LLT
    14.0 10042613 - Surgical and medical procedures 10021415 Immediate postoperative analgesia LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000656-18 Sponsor Protocol Number: 2042015 Start Date*: 2018-11-09
    Sponsor Name:SINTETICA SA
    Full Title: Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial, to evaluate, in pediatric population undergoing 'Calcaneo stop' surgery or Inguinal hernia repair, the ...
    Medical condition: Pediatric patients undergoing surgery of flatfoot or inguinal hernia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10002325 Anesthesia local LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2019-003758-97 Sponsor Protocol Number: MEX-NM-303 Start Date*: 2020-06-24
    Sponsor Name:Lupin Europe GmbH
    Full Title: Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Mexiletine in Paediatric Patients with Myotonic Disorders Who Have Completed MEX-NM-301 and MEX-NM-302 Studies
    Medical condition: Myotonic disorders: Nondystrophic myotonias (NDM) or myotonic dystrophies (DM, type 1 or type 2); ICD-10 code G71.1
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10028658 Myotonic disorders LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004190-46 Sponsor Protocol Number: D5136C00013 Start Date*: Information not available in EudraCT
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor versus Placebo in Reducing the Number of Vaso-Occlusive Crises in Paediatric Patients A...
    Medical condition: Sickle Cell Disease
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004850 10040645 Sickle cell disease NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-000137-14 Sponsor Protocol Number: PDC-01-0206 Start Date*: 2021-05-04
    Sponsor Name:Cessatech A/S
    Full Title: Pharmacokinetic study of intranasal CT001 in children 1-17 years of age undergoing elective surgical procedures
    Medical condition: Management of acute pain in children 1-17 years with the objective of preventing pain and distress associated with painful medical procedures in children.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2022-002955-20 Sponsor Protocol Number: ADENO-beta Start Date*: 2023-11-22
    Sponsor Name:AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO
    Full Title: Double-blind randomized controlled study versus placebo to evaluate the efficacy of mono-administration of betamethasone in children with symptomatic Adenovirus infection (ADENO-beta).
    Medical condition: Pediatric patients diagnosed with symptomatic Adenovirus infection.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10060931 Adenovirus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-005416-42 Sponsor Protocol Number: KF001 Start Date*: 2015-05-08
    Sponsor Name:Uppsala University. Department of Women's and children's health
    Full Title: Clondine in repeated doses for children in pain - a farmacokinetic study
    Medical condition: Pain in children
    Disease: Version SOC Term Classification Code Term Level
    18.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003310-40 Sponsor Protocol Number: 1SPR11002 Start Date*: 2014-01-27
    Sponsor Name:Luitpold Pharmaceuticals, Inc.
    Full Title: A Single Arm, Open Label Study of the Safety, Efficacy, and Pharmacokinetics of SPRIX® (intranasal ketorolac tromethamine) in 0 to 11 year-Old Patients Undergoing Open Surgical Procedures
    Medical condition: post open surgery pain (incuding but not limited to orthopedic, abdominal, thoracic, plastic/reconstructive, neurologic [spine], or urologic procedures)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002627-35 Sponsor Protocol Number: TAK-667-3001 Start Date*: 2022-07-25
    Sponsor Name:Takeda Pharmaceutical Company Limited
    Full Title: A Multicenter, Open-Label, Non-randomized Phase 3 Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneous Administration of Icatibant (TAK-667) in Japanese Children and Adolescent...
    Medical condition: Hereditary Angioedema
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-000624-37 Sponsor Protocol Number: CLOBOF3-17IA03 Start Date*: 2022-10-05
    Sponsor Name:Laboratorios Salvat, S.A.
    Full Title: A Phase 3, multicenter, randomized, evaluator-blinded clinical trial to assess the safety and efficacy of Clobetasol propionate ophthalmic nanoemulsion, 0.05% compared to Prednisolone acetate, 1% i...
    Medical condition: Inflammation and pain associated with ocular surgery.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10015943 Eye inflammation PT
    20.0 10015919 - Eye disorders 10015958 Eye pain PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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