In short
Clinical trials investigating ANHYDROUS NALOXONE HYDROCHLORIDE are being used in studies of severe acute trauma-related pain in children. These trials mainly look at treatment effectiveness and pain relief in a pediatric emergency setting, with careful measurement of pain change over time.
Key points
- Only one trial is provided for ANHYDROUS NALOXONE HYDROCHLORIDE in the source data. It is a Phase 2 interventional study in children with severe acute trauma-related pain. The study is authorised and plans to enroll 116 participants. The main outcome is pain change measured with a visual analog scale over 30 minutes. The trial setting is the pediatric emergency department, and the study compares treatment approaches for severe limb trauma pain.
Trial overview
The source data include one interventional study, which means researchers are giving treatments and then measuring the results. This study is titled “RANDOMIZED CONTROLLED STUDY COMPARING SUFENTANIL AND KETAMINE INTRANASALLY IN THE MANAGEMENT OF SEVERE ACUTE TRAUMA-RELATED PAIN IN CHILDREN.” The trial is authorised and is listed as Phase 2.
Study population and setting
The trial focuses on children who are admitted to the pediatric emergency department with severe acute trauma-related pain. The brief summary says the setting is limb trauma, which means injury to an arm or leg. The source data do not list full inclusion or exclusion rules, so the exact participation criteria are not fully shown.
Study design and treatment comparison
The study is described as a randomized controlled study, which means participants are assigned to different treatment groups by chance and the results are compared. The brief summary says the trial compares the analgesic efficacy, meaning pain-relief effect, of intranasal sufentanil with intranasal ketamine for severe pain in children. The interventions listed also include EMLA cream, naloxone injection, and Entonox inhalation as part of the study record.
Phase and enrollment
This study is in Phase 2, a stage that usually looks more closely at how well a treatment works in a defined patient group. The planned enrollment is 116, which is the number of participants the trial aims to include.
Main outcome measures
The main outcome is pain intensity, measured with the vertical visual analog scale, or VAS. Researchers measure pain at the start of treatment, called T0, and again at 30 minutes, called T30. The main comparison is the change in pain from T0 to T30, written in the study record as ∆intensity = IntensityT30 – IntensityT0.
What this means for patients
For families, this trial is mainly about finding the best way to reduce severe pain after trauma in children in an emergency setting. The study is focused on short-term pain relief and compares how much pain changes within the first 30 minutes after treatment. Because the source data are limited, it is not possible to describe extra eligibility details or additional results beyond what is listed in the trial record.