Intravenous Hydromorphone for the Treatment of Acute Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Chest Pain
• Intervention / Treatment: Drug: Hydromorphone

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hao Sun, MD, PhD; Phone Number: 86 13584017821; Email: haosun_6@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Hao Sun, MD, PhD; Phone Number: 86 13584017821; Email: haosun_6@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time.	Drug: Hydromorphone; Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief at 30 Minutes After Administration	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.	30 minutes post-medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS Pain Scores Over 60 Minutes	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.	0, 5, 15, 30, 45, and 60 minutes after administration (plus 5 minutes after any additional dose)
Analgesia Success Rate	The proportion of patients who do not require any additional analgesics within 60 minutes after the initial administration.	Up to 60 minutes post-administration
Adverse Events Within 60 Minutes	Incidence of adverse events (e.g., hypoventilation, bradycardia, nausea, vomiting, itching, or requirement of naloxone) within 60 minutes after administration.	60 minutes post-administration
Total Dose of Rescue Medication	The cumulative dose of any rescue medication administered within 60 minutes after the initial analgesic administration.	60 minutes post-administration
Blood Drug Concentration	Measurement of drug concentrations from blood samples collected at baseline, 2, 6, 12, and 24 hours after administration, to assess pharmacokinetics.	Baseline; 2, 6, 12, and 24 hours post-administration
Oxygen Saturation	Measurement of oxygen saturation recorded at baseline, 15, 30, 45, and 60 minutes post-administration.	Baseline; 15, 30, 45, and 60 minutes post-administration
Respiratory Rate	Measurement of respiratory rate recorded at baseline, 15, 30, 45, and 60 minutes post-administration.	Baseline; 15, 30, 45, and 60 minutes post-administration
Systolic Blood Pressure	Measurement of systolic blood pressure recorded at baseline, 15, 30, 45, and 60 minutes post-administration.	Baseline; 15, 30, 45, and 60 minutes post-administration

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: Yichang Humanwell Pharmaceutical Co., Ltd., China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Chest Pain; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Hydromorphone
• Other Study ID Numbers: 2024-320-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No