Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000292673
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
5/09/2005
Date last updated
5/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Hydromorphone Trial
Scientific title
A Preliminary Crossover Study of the Pharmacokinetics and Clinical Efficacy of Hydromorphone Nasal Analgesia Spray versus Intravenous Hydromorphone for Postoperative Pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia for Postoperative Pain 380 0
Condition category
Condition code
Alternative and Complementary Medicine 451 451 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of intranasal versus intravenous hydromorphone given in the postoperative period. Single-dose to be administered via first route (randomised order) at first onset of pain postoperatively, then single-dose via second route to be administered for pain between 12 and 24 hours later. Fentanyl PCIA for breakthrough pain in between these 2 doses.
Intervention code [1] 277 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 512 0
Clinical effectiveness of a single dose of 2mg hydromorphone administered intranasally, as measured by redution of pain intensity at rest, compared with the administration of 1mg hydromorphone intravenously.
Timepoint [1] 512 0
Pain scores (visual analogue scale - VAS) will be collected immediately prior to (baseline) and at 5, 15, 30, 60, 120 and 180 minutes after each method of hydromorphone administration.
Secondary outcome [1] 1098 0
Nausea, sedation and pruritus scores (VAS).
Timepoint [1] 1098 0
Collected immediately prior to and 60 minutes after hydromorphone administration.
Secondary outcome [2] 1099 0
Presence of side effects including pain or burning in the nasal passages.
Timepoint [2] 1099 0
After intransal administration.
Secondary outcome [3] 1100 0
Patient preference/acceptability - intranasal versus intravenous.
Timepoint [3] 1100 0
Secondary outcome [4] 1101 0
Change in oxygen saturation post dose measured by pulse oximetry.
Timepoint [4] 1101 0
Secondary outcome [5] 1102 0
Drug Kinetics (bioavailability, volume of distribution, elimination) of intranasal hydromorphone.
Timepoint [5] 1102 0
Blood sampled via IV cannula at 2, 5, 15, 30, 60, 120, 180 minutes after administration for both routes.

Eligibility
Key inclusion criteria
ASA 1 or 2. Major Gynaecological Surgery involving skin or mucosal incision (e.g. laparotomy, total abdominal hysterectomy, vaginal hysterectomy +/- anterior/posterior repair).Decision to use patient controlled intravenous analgesia (PCIA) in the postoperative period.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Nasal pathology.Allergy to shellfish (chitosan a natural constituent of mollusc seashell is added to the hydromorphone mixture to aid in prolonging mucosal absorption).Intolerance to opioids.Decision to use epidural analgesia postoperatively.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque envelop used to conceal route of first administration until time of dose
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin Square Cross Over Design
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 500 0
Other Collaborative groups
Name [1] 500 0
ANZCA 2004 Grant
Country [1] 500 0
Primary sponsor type
Individual
Name
Stephen Lim
Address
Senior Pharmacist
Pharmacy Department
Women & Children's Health Services
Subiaco
Perth WA 6008
Country
Australia
Secondary sponsor category [1] 409 0
Individual
Name [1] 409 0
Professor Michael Paech, King Edward Memorial Hospital
Address [1] 409 0
374 Bagot Road, Subiaco, Perth, Western Australia, 6008
Country [1] 409 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1482 0
King Edward Memorial Hospital
Ethics committee address [1] 1482 0
374 Bagot Road, Subiaco, Perth WA, 6008
Ethics committee country [1] 1482 0
Australia
Date submitted for ethics approval [1] 1482 0
Approval date [1] 1482 0
Ethics approval number [1] 1482 0

Summary
Brief summary
Hydromorphone is an opiate drug quite similar to morphine and is widely used to treat pain after surgery. A recent idea is to use a patient controlled technique which allows the patient to self-administer the drug as they need using a nasal spray. Previous studies show the absorption of hydromorphone through the nasal mucosa is rapid within a few minutes and that pain relief is very effective. The advantage of this route of delivery is that it avoids the use of intravenous drips. In this study we will be comparing the intravenous route of administration with what happens after a similar dose of hydromorphone is given intranasally. This will help to detemine the most appropriate way to prepare the nasal drug and the best dose to give with each spray. Postoperatively patients who are using patient controlled intravenous analgesia will be given a dose of hydromorphone for pain before they are allowed to start using their pump. All patients will get an intravenous and an intransal dose 12-24 hours apart. The order of which comes first will be randomly allocated. Blood wil be taken from a previously sited cannula at intervals before and after doses to measure levels. At all times good pain relief is guaranteed by use of the fentanyl PCIA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35378 0
Address 35378 0
Country 35378 0
Phone 35378 0
Fax 35378 0
Email 35378 0
Contact person for public queries
Name 9466 0
Professor Michael Paech or Research Nurses, Desiree Cavill & Tracy Bingham
Address 9466 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco Perth WA 6008
Country 9466 0
Australia
Phone 9466 0
+61 8 93402222 Pager 3223 (Mike Paech) or 3433 (Research Nurses)
Fax 9466 0
+61 8 93402260
Email 9466 0
[email protected]
Contact person for scientific queries
Name 394 0
Professor Michael Paech
Address 394 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco Perth WA 6008
Country 394 0
Australia
Phone 394 0
+61 8 93402222 Pager 3223
Fax 394 0
+61 8 93402260
Email 394 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.