The Hydromorphone Trial

A Preliminary Crossover Study of the Pharmacokinetics and Clinical Efficacy of Hydromorphone Nasal Analgesia Spray versus Intravenous Hydromorphone for Postoperative Pain

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000292673

Enrollment

Registered

2005-09-05

Start date

2004-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

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.

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.

Outcome results