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Recruiting NCT06949059

Intravenous Hydromorphone for the Treatment of Acute Pain

Phase I / Phase II Interventional Acute Chest Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydromorphone.
Who it may be relevant to
Registry conditions: Acute Chest Pain. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Intravenous Acetaminophen Versus Intravenous Hydromorphone for the Treatment of Acute Pain: A Single-Center, Prospective, Single-Arm Study

Overview

To observe the efficacy and safety of hydromorphone in the treatment of acute chest pain, and to explore the potential advantages of hydromorphone for analgesia in patients with acute chest pain, so as to provide more theoretical basis for individualized analgesia and rapid recovery in patients with acute chest pain.

Interventions

  • Drug Hydromorphone
    Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time.

Primary outcome measures

  • Pain Relief at 30 Minutes After Administration [Time frame: 30 minutes post-medication]
Secondary outcome measures (8)
  • NRS Pain Scores Over 60 Minutes [Time frame: 0, 5, 15, 30, 45, and 60 minutes after administration (plus 5 minutes after any additional dose)]
  • Analgesia Success Rate [Time frame: Up to 60 minutes post-administration]
  • Adverse Events Within 60 Minutes [Time frame: 60 minutes post-administration]
  • Total Dose of Rescue Medication [Time frame: 60 minutes post-administration]
  • Blood Drug Concentration [Time frame: Baseline; 2, 6, 12, and 24 hours post-administration]
  • Oxygen Saturation [Time frame: Baseline; 15, 30, 45, and 60 minutes post-administration]
  • Respiratory Rate [Time frame: Baseline; 15, 30, 45, and 60 minutes post-administration]
  • Systolic Blood Pressure [Time frame: Baseline; 15, 30, 45, and 60 minutes post-administration]

Eligibility criteria

Inclusion criteria

  • Age 18-64 years old;
  • Gender is not limited;
  • Patients with acute chest pain, with the time from pain onset to visit the doctor ≤ 24 days;
  • Severe pain that requires the use of opioids to control as determined by emergency physicians;
  • Obtain informed consent from the patient or family members.

Exclusion criteria

  • Known allergy to hydromorphone or morphine;
  • Systolic blood pressure <100 mmHg, oxygen saturation <95%, pulse less than 60 beats/min;
  • Use of acetaminophen or nonsteroidal anti-inflammatory drugs in the past 8 hours;
  • Chronic pain, defined as pain lasting for more than 12 weeks;
  • Delirium, alcohol withdrawal symptoms or other drug intoxication;
  • Pregnant or lactating women;
  • Patients with mental or neurological diseases, cognitive and consciousness disorders and inability to express correctly;
  • Participating in any other research at the same time;
  • Factors that increase the risk of participating in the study (life-threatening chest pain patients who require rapid diagnosis or treatment intervention, such as resuscitation status, excluding chest pain caused by myocardial infarction), who are judged by the researchers to be unsuitable for inclusion in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanjing Drum Tower Hospital — Nanjing

Identifiers

NCT: NCT06949059 · 2024-320-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗