Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000246684
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
31/08/2005
Date last updated
31/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety of Tramadol in Breastfeeding
Scientific title
Safety of Tramadol in Breastfeeding - A Study of the Postoperative Use of Tramadol following Caesarian Section
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Caesarean Section Analgesia and Breastfeeding 333 0
Condition category
Condition code
Reproductive Health and Childbirth 384 384 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tramadol is widely used in breastfeeding but it is unclear exactly how much is transferred into breast milk. This study will look at levels of tramadol and its metabolite (M1) in breast milk and blood after regular administration (100 mg 6 hourly). Milk samples will be taken immediately prior to 4th dose, and 2 more samples plus one blood sample taken in dosing interval between 4th and 5th doses. Baby also assessed for tone and alertness after 4th dose.
Intervention code [1] 278 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 442 0
Quantitative analyses of tramadol and its metabolite (M1) in breast milk and maternal blood for pharmacokinetic analysis
Timepoint [1] 442 0
Secondary outcome [1] 973 0
Assessment of infant after administration of tramadol to breast feeding mother (100 mg 6 hourly x 4 doses) using Neurological and Adaptive Capacity Score (NACS).
Timepoint [1] 973 0

Eligibility
Key inclusion criteria
ASA 1 or 2. Day 3 post Caesarean section.Happy to take tramadol as part of postoperative analgesia regime.Breastfeeding.Epidural for postoperative pain relief removed.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Known sensitivity to tramadol.Significant renal dysfunction.Decision not to breastfeed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 437 0
Other Collaborative groups
Name [1] 437 0
ANZCA Research Grant 2004
Country [1] 437 0
Australia
Primary sponsor type
Individual
Name
Professor Michael Paech
Address
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Perth WA 6008
Country
Australia
Secondary sponsor category [1] 355 0
Individual
Name [1] 355 0
Associate Professor Ken Ilett
Address [1] 355 0
Country [1] 355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1410 0
King Edward Memorial Hospital
Ethics committee address [1] 1410 0
374 Bagot Road, Subiaco, Perth, WA, 6008
Ethics committee country [1] 1410 0
Australia
Date submitted for ethics approval [1] 1410 0
Approval date [1] 1410 0
Ethics approval number [1] 1410 0

Summary
Brief summary
In this study we wish to find out how much of the pain relieving drug tramadol, given to women after caesarean section, passes into breast milk. The information will be used to inform lactating women about the risk versus benefit of taking tramadol during early breast feeding. Tramadol has been used overseas for many years but only became available in Australia in 1998. It is now widely used in the treatment of many types of pain and is particularly useful after surgery. There is very little information about the transfer of tramadol and its break-down products into breast milk. One study looking at a single dose of tramadol suggests single doses are unlikely to be a problem, but there is not enough information to be certain about the safety of tramadol for new-born babies when mothers who are breast feeding are taking repeated doses. If the infant was affected in any way this would probabvly be seen as sleepiness, floppiness and poor feeding. We aim to obtain iformation about how much tramadol passes to the breast feeding infant and be able to advise about the likelihood of significant adverse effects. 75 women taking oral tramadol regularly (100 mg every 6 hours)for postoperative pain control will be recruited after removal of their patient controlled epidural analgesia device, usually on day 3 post caesarean section. Breast milk samples will be taken just before the fourth dose and in between the 4th and 5th doses along with a single blood sample. The milk and blood sample will be sent to the laboratory to measure the amount of tramadol and its break-down product. The baby will also be assessed afte the 4th dose for tone and alertness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35966 0
Address 35966 0
Country 35966 0
Phone 35966 0
Fax 35966 0
Email 35966 0
Contact person for public queries
Name 9467 0
Professor Michael Paech or Research Nurses, Desiree Cavill & Tracy Bingham
Address 9467 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco Perth WA 6008
Country 9467 0
Australia
Phone 9467 0
+61 8 93402222 Pager 3223 (Mike Paech) or 3433 (Research Nurses)
Fax 9467 0
+61 8 93402260
Email 9467 0
Michael.Paech@health.wa.gov.au
Contact person for scientific queries
Name 395 0
Professor Michael Paech
Address 395 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco Perth WA 6008
Country 395 0
Australia
Phone 395 0
+61 8 93402222 Pager 3223
Fax 395 0
+61 8 93402260
Email 395 0
Michael.Paech@health.wa.gov.au

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
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Documents added automatically
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