Clinical Trials Logo

Clinical Trial Summary

Patients with Head & Neck Squamous Cell Carcinoma often need a gastrostomy. It can be performed with a radiological approach. This procedure is usually not performed under general anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric insufflation and incision of the abdominal wall. Standard analgesic treatments are usually not well-fitted due to onset of action or route of administration. An alternative solution could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use allowing repetition if needed, during the procedure.

The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT® to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH®), in radiologic percutaneous gastrostomy tube placement:

- during the procedure

- following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure).

Secondary purposes are to compare easiness of 2 treatments and their adverse effects.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02869321
Study type Interventional
Source Central Hospital, Nancy, France
Contact
Status Completed
Phase Phase 4
Start date May 2015
Completion date May 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03959878 - Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes. N/A
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Recruiting NCT04110613 - RCT: Early Feeding After PEG Placement N/A
Completed NCT03319576 - Early Feeding Following Percutaneous Gastrostomy Tube Placement N/A
Completed NCT03575754 - A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique N/A
Enrolling by invitation NCT06129877 - CHAMP App Feeding Difficulties Repository
Completed NCT04183296 - The Effect of Total Intravenous Anesthesia and Volatile Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Laparoscopic or Robotic Assisted Gastrectomy N/A
Recruiting NCT02909205 - a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised N/A
Recruiting NCT04636099 - Gastrointestinal Surgery Study Group 2001 N/A
Recruiting NCT06464978 - Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy N/A
Not yet recruiting NCT05955534 - Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy N/A
Recruiting NCT05205343 - Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
Recruiting NCT03874871 - Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
Completed NCT03252509 - Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors N/A
Completed NCT04804631 - Tube Feeding in Children Having a Bone Marrow Transplant
Terminated NCT01825564 - Comparison of RightSpot pH Indicator & RightLevel pH Detector With X-Ray Verification for FT or G-Tube Placement N/A
Completed NCT04919577 - Predictive Factors for Roux Stasis Syndrome
Completed NCT04151030 - Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure N/A
Not yet recruiting NCT06431048 - No DIET Trial: Dogmatic Interruption of Enteral nuTrition N/A
Completed NCT05994079 - Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy N/A