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

NCT ID: NCT03375515

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-29
• Study Completion Date: 2020-01-10

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.

Detailed Description

The opioid dose for individual with cancer pain to provide adequate relief of pain with an acceptable degree of side effects is variable. Opioid titration is a process to obtain the tailored dose. Conventional titration is administered by a clinician or nurse. PCA is that patients control cancer pain by self-administration of intravenous opioids using programmable pump. The aim of our study is to evaluate the efficacy of PCA titration versus conventional titration intravenously for severe cancer pain (10-point numerical rating scale, NRS ≥ 7). Injectable Hydromorphone was selected as pharmaceutical analgesics, which works as well as morphine and oxycodone and had similar side effects.

Conditions

Cancer Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCA IV Hydromorphone titration

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.

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: 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 pump

Intervention Type: 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.

non-PCA IV Hydromorphone titration

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.

Group Type: ACTIVE_COMPARATOR

Hydromorphone

Intervention Type: 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.

Interventions

Hydromorphone

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.

Intervention Type: DRUG

PCA pump

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. With written informed consent signed voluntarily by patients themselves.

2. Cancer patients aged 18-70 years old.

3. Patients with cancer pain more than or equal to NRS 7 during previous 24 hours.

4. Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study.

5. Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization.

6. Patients or his/her caregivers who are able to fill out the questionnaire forms.

7. Ability to correctly understand and cooperate with medication guidance of doctors and nurses.

8. Without a history of anaphylaxis of narcotic drugs.

9. Without psychiatric problems.

10. ECOG performance status ≤3.

11. Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）.

Exclusion Criteria

1. Patients diagnosed with non-cancer pain or unexplained pain.

2. Patients suffered with post-op pain.

3. Patients having paralytic ileus.

4. Patients who have hypersensitivity to hydromorphone.

5. 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.

6. Patients having a incoercible Nausea and vomiting.

7. Monoamine oxidase inhibitor (MAOI) was administrated two week before randomization.

8. Patients who are pregnant or lactating,who plans to be pregnant within one month after the trial（including male）.

9. Patients who are opioid abuse.

10. Patients who are alcohol abuse.

11. Patients who are cognitive dysfunction.

12. Patients having a severe psychotic depression.

13. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unable to participate in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rongbo Lin

Role: STUDY_DIRECTOR

Fujian Cancer Hospital

Locations

Rongbo Lin

Fuzhou, Fujian, China

Countries

China

Other Identifiers

HMORCT09-1

Identifier Type: -

Identifier Source: org_study_id