The absorption of fentanyl from a new wafer in patients who have had major surgery

The pharmacokinetics and acceptability of a sublingual fentanyl wafer in postoperative patients who have had major gynaecological surgery

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000743268

Enrollment

Registered

2009-08-26

Start date

2009-11-25

Completion date

2011-11-16

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

The pharmacokinetics of a new formulation of fentanyl citrate are being evaluated in postoperative patients

Interventions

A single administration of sublingual fentanyl wafer 50 mcg and single administration of intravenous fentanyl 50 mcg, in randomised order, with an 18 hour washout period, after major gynaecological surgery among patients having patient-controlled intavenous morphine

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

Age 18-70 years Gynaecological surgery Using intravenous morphine patient -controlled analgesia postoperatively

Exclusion criteria

Oral pathology Intolerance of opioids Pregnancy

Outcome results