PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain

NCT03375515 | Completed Phase 3 DMC

• 1 other identifier: HMORCT09-1
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

A large number of studies have shown that patients feel more satisfied with hydromorphone in the pain management. and a systematic review found that hydromorphone may be better suited than morphine for titration of acute analgesia. However, current researches on intravenous opioid titration for cancer pain such as hydromorphone are relatively insufficient in China. Therefore, a prospective, multi-center, randomized controlled study is conducted to assess the efficacy and safety of comparing patient-controlled analgesia (PCA) versus non-PCA intravenous hydromorphone titration for severe cancer pain.

Conditions

Cancer Pain

Keywords

hydromorphone titration

Outcome Measures

Primary Outcomes (1)

• The time of successful titration in 24 hours

  The satisfied pain control was defined NRS pain score ≤ 3 at rest in at least 2 consecutive assessment (15 minutes interval). The time needed to successful titration was extended to achieve satisfied pain control again if NRS pain score ≥ 7 after satisfied pain control within 24 hours. The failure of successful titration was defined that satisfied pain control does not achieve within 24 hours.

  In 24 hours

Secondary Outcomes (7)

• The percentage of patients titrated successfully within 60 minutes

  Up to 60 minutes

• The percentage of patients titrated successfully within 24 hours

  Up to 24 hours

• The mean NRS pain score of 24 hours

  Up to 24 hours

• The total dose of hydromorphone titrated from start of titration to TST

  Up to 24 hours

• The total dose of hydromorphone titrated within 24 hrs

  Up to 24 hours

Study Arms (2)

PCA IV Hydromorphone titration

EXPERIMENTAL

PCA titration using programmable pump: bolus hydromorphone at 0.5mg (for opioid intolerance) or hydromorphone dose equivalent to 10% to 20% of the total opioid taken in the previous 24 hours with a lockout time 15 min (for opioid tolerance) was administered by the patients educated. No basal infusion was set in the pump.Repeated assessment of NRS score with a interval of 15 minutes until stable pain control. Then Repeated assessment of NRS score with a interval of 1 hour. The titration will be done on the patient's request (manipulation by the patient himelf/herself) in 24hrs.

Drug: Hydromorphone; Device: PCA pump

non-PCA IV Hydromorphone titration

ACTIVE COMPARATOR

Non-PCA titration administered by a nurse or clinician: Initial hydromorphone doses were same with PCA titration. Repeated assessment of NRS score with a interval of 15 minutes until stable pain control. Then Repeated assessment of NRS score with a interval of 1 hour. The dose of hydromorphone increased by 50%-100% if pain unchanged or increased, or repeat same dose if pain decrease to 4-6. The titration will be done on the patient's request (manipulation by a nurse) in 24hrs.

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

1. For opioid-intolerant patients: continuous infusion of hydromorphone 0 mg per hour, and a demand dose of 0.5 mg with a lockout interval of 15 minutes. 2. For opioid-tolerant patients: basal rate 0 mg per hour, and a demand dose of 10% of the hydromorphone dose equivalent to the total opioid taken in the previous 24 hrs with a lockout interval of 15 minutes.

PCA IV Hydromorphone titration; non-PCA IV Hydromorphone titration

PCA pump DEVICE

1. For opioid-intolerant patients: initial dose 0.5 mg intravenous hydromorphone. 2. For opioid-tolerant patients: intravenous hydromorphone with a initial dose equivalent to 10%(5-15%) of the total opioid taken in the previous 24 hrs.

PCA IV Hydromorphone titration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With written informed consent signed voluntarily by patients themselves.
• Cancer patients aged 18-70 years old.
• Patients with cancer pain more than or equal to NRS 7 during previous 24 hours.
• Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study.
• Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization.
• Patients or his/her caregivers who are able to fill out the questionnaire forms.
• Ability to correctly understand and cooperate with medication guidance of doctors and nurses.
• Without a history of anaphylaxis of narcotic drugs.
• Without psychiatric problems.
• ECOG performance status ≤3.

You may not qualify if:

• Patients diagnosed with non-cancer pain or unexplained pain.
• Patients suffered with post-op pain.
• Patients having paralytic ileus.
• Patients who have hypersensitivity to hydromorphone.
• There are abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold,to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade.
• Patients having a incoercible Nausea and vomiting.
• Monoamine oxidase inhibitor (MAOI) was administrated two week before randomization.
• Patients who are pregnant or lactating,who plans to be pregnant within one month after the trial（including male）.
• Patients who are opioid abuse.
• Patients who are alcohol abuse.
• Patients who are cognitive dysfunction.
• Patients having a severe psychotic depression.
• Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unable to participate in a clinical trial.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Rongbo Lin

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Rongbo Lin

  Fujian Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: September 29, 2018
• Primary Completion: December 10, 2019
• Study Completion: January 10, 2020
• Last Updated: March 8, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)