Intravenous Hydromorphone for the Treatment of Acute Pain

NCT06949059 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-320-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Chest Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• NRS Pain Scores Over 60 Minutes

  0, 5, 15, 30, 45, and 60 minutes after administration (plus 5 minutes after any additional dose)

• Analgesia Success Rate

  Up to 60 minutes post-administration

• Adverse Events Within 60 Minutes

  60 minutes post-administration

• Total Dose of Rescue Medication

  60 minutes post-administration

• Blood Drug Concentration

  Baseline; 2, 6, 12, and 24 hours post-administration

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

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

Treatment Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Hao Sun, MD, PhD

CONTACT

13584017821; haosun_6@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 29, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)