Clinical trial NCT06949059: Intravenous Hydromorphone for the Treatment of Acute Pain
Official title: Intravenous Acetaminophen Versus Intravenous Hydromorphone for the Treatment of Acute Pain: A Single-Center, Prospective, Single-Arm Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Chest Pain
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Yichang Humanwell Pharmaceutical Co., Ltd., China
First posted: 2025-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

1. Known allergy to hydromorphone or morphine;
2. Systolic blood pressure \<100 mmHg, oxygen saturation \<95%, pulse less than 60 beats/min;
3. Use of acetaminophen or nonsteroidal anti-inflammatory drugs in the past 8 hours;
4. Chronic pain, defined as pain lasting for more than 12 weeks;
5. Delirium, alcohol withdrawal symptoms or other drug intoxication;
6. Pregnant or lactating women;
7. Patients with mental or neurological diseases, cognitive and consciousness disorders and inability to express correctly;
8. Participating in any other research at the same time;
9. 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.

Primary outcomes:
measure: Pain Relief at 30 Minutes After Administration
timeFrame: 30 minutes post-medication
Secondary outcomes:
measure: NRS Pain Scores Over 60 Minutes
timeFrame: 0, 5, 15, 30, 45, and 60 minutes after administration (plus 5 minutes after any additional dose)
measure: Analgesia Success Rate
timeFrame: Up to 60 minutes post-administration
measure: Adverse Events Within 60 Minutes
timeFrame: 60 minutes post-administration
measure: Total Dose of Rescue Medication
timeFrame: 60 minutes post-administration
measure: Blood Drug Concentration
timeFrame: Baseline; 2, 6, 12, and 24 hours post-administration
measure: Oxygen Saturation
timeFrame: Baseline; 15, 30, 45, and 60 minutes post-administration
measure: Respiratory Rate
timeFrame: Baseline; 15, 30, 45, and 60 minutes post-administration
measure: Systolic Blood Pressure
timeFrame: Baseline; 15, 30, 45, and 60 minutes post-administration
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
References: