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ANHYDROUS NALOXONE HYDROCHLORIDE

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.

Table of Contents

Trial overview

The source data include one interventional study, which means researchers are giving treatments and then measuring the results.[1] This study is titled “RANDOMIZED CONTROLLED STUDY COMPARING SUFENTANIL AND KETAMINE INTRANASALLY IN THE MANAGEMENT OF SEVERE ACUTE TRAUMA-RELATED PAIN IN CHILDREN.”[1] The trial is authorised and is listed as Phase 2.[1]

Study population and setting

The trial focuses on children who are admitted to the pediatric emergency department with severe acute trauma-related pain.[1] The brief summary says the setting is limb trauma, which means injury to an arm or leg.[1] The source data do not list full inclusion or exclusion rules, so the exact participation criteria are not fully shown.[1]

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.[1] 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.[1] The interventions listed also include EMLA cream, naloxone injection, and Entonox inhalation as part of the study record.[1]

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.[1] The planned enrollment is 116, which is the number of participants the trial aims to include.[1]

Main outcome measures

The main outcome is pain intensity, measured with the vertical visual analog scale, or VAS.[1] Researchers measure pain at the start of treatment, called T0, and again at 30 minutes, called T30.[1] The main comparison is the change in pain from T0 to T30, written in the study record as ∆intensity = IntensityT30 – IntensityT0.[1]

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.[1] The study is focused on short-term pain relief and compares how much pain changes within the first 30 minutes after treatment.[1] 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.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06968546 Phase 2 Severe acute trauma-related pain Authorised 116

FAQ

  • What is being studied in trials of ANHYDROUS NALOXONE HYDROCHLORIDE? The trial data provided focus on severe acute trauma-related pain in children. The study compares pain treatment approaches in the pediatric emergency department.
  • Who can take part in these trials? The available trial information points to children admitted to the pediatric emergency department with limb trauma and severe pain. Exact entry rules are not listed in the source data.
  • What phase is the trial? The study is listed as Phase 2. This means it is testing how well the treatment works and continuing to assess safety in a defined patient group.
  • What outcome is being measured? The main outcome is pain intensity, measured with a vertical visual analog scale, also called VAS. The study compares the change in pain from the start of treatment to 30 minutes later.
  • How many people are planned for the study? The planned enrollment is 116 participants. This is the number of patients the trial aims to include.

Ongoing Clinical Trials on ANHYDROUS NALOXONE HYDROCHLORIDE

  • Comparing intranasal sufentanil and ketamine for severe acute trauma-related pain management in children admitted to pediatric emergency care

    Recruiting

    2 1 1 1
    Investigated drugs:
    France

Glossary

  • Clinical trial: A research study in people that tests a medical treatment or compares treatments.
  • Interventional study: A study where researchers give a treatment and observe what happens.
  • Phase 2: A trial stage that looks more closely at whether a treatment works and continues to monitor safety.
  • Pediatric emergency department: A hospital area that gives urgent care to children.
  • Severe acute trauma-related pain: Strong pain that starts suddenly after an injury or trauma.
  • Limb trauma: An injury to an arm or leg.
  • Visual analog scale (VAS): A pain scale used to show how strong pain feels, often from no pain to worst pain.
  • Enrollment: The number of people a study plans to include.
  • Effectiveness: How well a treatment works for the problem being studied.
  • Primary outcome: The main result the researchers are measuring in the trial.

References