Acute Chest Pain
Conditions
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.
Interventions
DRUGHydromorphone
Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time.
Sponsors
Yichang Humanwell Pharmaceutical Co., Ltd., China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief at 30 Minutes After Administration | 30 minutes post-medication | The difference between the NRS pain score before medication and the NRS pain score at 30 minutes after administration (i.e., NRS\_before-NRS\_at\_30min). A larger value indicates a better analgesic effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia Success Rate | Up to 60 minutes post-administration | The proportion of patients who do not require any additional analgesics within 60 minutes after the initial administration. |
| Adverse Events Within 60 Minutes | 60 minutes post-administration | Incidence of adverse events (e.g., hypoventilation, bradycardia, nausea, vomiting, itching, or requirement of naloxone) within 60 minutes after administration. |
| Total Dose of Rescue Medication | 60 minutes post-administration | The cumulative dose of any rescue medication administered within 60 minutes after the initial analgesic administration. |
| NRS Pain Scores Over 60 Minutes | 0, 5, 15, 30, 45, and 60 minutes after administration (plus 5 minutes after any additional dose) | NRS pain scores will be measured at baseline (before administration) and at 5, 15, 30, 45, and 60 minutes post-administration. If additional analgesics or rescue medication are given, the NRS is re-measured 5 minutes afterward. |
| Oxygen Saturation | Baseline; 15, 30, 45, and 60 minutes post-administration | Measurement of oxygen saturation recorded at baseline, 15, 30, 45, and 60 minutes post-administration. |
| Respiratory Rate | Baseline; 15, 30, 45, and 60 minutes post-administration | Measurement of respiratory rate recorded at baseline, 15, 30, 45, and 60 minutes post-administration. |
| Systolic Blood Pressure | Baseline; 15, 30, 45, and 60 minutes post-administration | Measurement of systolic blood pressure recorded at baseline, 15, 30, 45, and 60 minutes post-administration. |
| Blood Drug Concentration | Baseline; 2, 6, 12, and 24 hours post-administration | Measurement of drug concentrations from blood samples collected at baseline, 2, 6, 12, and 24 hours after administration, to assess pharmacokinetics. |
Countries
China
Contacts
Primary ContactHao Sun, MD, PhD
Outcome results
None listed