Postoperative Pain Clinical Trial
Official title:
Open-label Evaluation of the Pharmacokinetic Profile, Safety, and Efficacy of Tapentadol Oral Solution for the Treatment of Post-surgical Pain in Children and Adolescents Aged From 2 Years to Less Than 18 Years.
To find out if a drug called tapentadol administered by mouth safely relieves pain in
children. Look at the amount of tapentadol in the blood after a single oral dose.
Tapentadol oral solution for children is still being tested and is not yet registered.
Tapentadol tablets are effective in treating both acute and chronic pain in adults. This
trial will help to understand how tapentadol oral solution works in children.
The lower age limit for the clinical trial was initially set to 3 years of age in the protocol. The trial planned for the inclusion of participants in three age categories. Age 3 to less than 6 years (young children), age 6 to less than 12 years (older children) and age 12 to less than 18 years of age (adolescents). There was a request by the Paediatric Committee (PDCO) at the European Medicines Agency to include participants 2 years of age (very young children). The protocol amendment thus planned to combine the two youngest age groups into a single reporting group. The protocol amendment only planned that the very young children group would have separate analysis for the Faces Pain Scale Revised (FPS-R) Scale and for the presentation of the serum concentrations, because the pharmacokinetic sampling scheme used in the 2 year old participants was different from the young children group (aged 3 to less than 6 years). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
| Recruiting |
NCT03181620 -
Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation
|
N/A | |
| Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
| Recruiting |
NCT06007378 -
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
|
N/A | |
| Recruiting |
NCT05943015 -
Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks
|
N/A | |
| Completed |
NCT04544228 -
Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
|
N/A | |
| Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
| Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
| Completed |
NCT03663478 -
Continuous TQL Block for Elective Cesarean Section
|
Phase 4 | |
| Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
| Completed |
NCT05170477 -
Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment
|
N/A | |
| Not yet recruiting |
NCT04561856 -
Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone
|
Phase 4 | |
| Completed |
NCT06425601 -
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy
|
N/A | |
| Completed |
NCT03612947 -
TAP Block in Laparoscopic Cholecystectomy.
|
Phase 2 | |
| Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
| Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
| Completed |
NCT04571515 -
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
|
Phase 2 | |
| Active, not recruiting |
NCT04190355 -
The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain
|
N/A | |
| Recruiting |
NCT05145153 -
Incidence of Chronic Pain After Thoracic Surgery
|
||
| Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |