Intravenous Hydromorphone for the Treatment of Acute Pain

Phase 1

Recruiting

• Conditions: Acute Chest Pain
• Interventions: Drug: Hydromorphone

• Registration Number: NCT06949059
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-21
• Last Update Submitted: 2025-04-21
• Study First Posted: 2025-04-29
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Hydromorphone	Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China