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Trial registered on ANZCTR
Registration number
ACTRN12612000531819
Ethics application status
Approved
Date submitted
20/02/2011
Date registered
21/05/2012
Date last updated
21/05/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Paracetamol Rectal Suppository for postoperative pain reduction in Abdominal Hysterectomy A Randomized controlled trial
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Scientific title
Paracetamol Rectal Suppository for postoperative pain reduction in Abdominal Hysterectomy A Randomized controlled trial
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Secondary ID [1]
259644
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none
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Universal Trial Number (UTN)
U1111-1119-5401
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
healthy woman and no underlying disease
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Condition category
Condition code
Renal and Urogenital
259361
259361
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0
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Other renal and urogenital disorders
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Oral and Gastrointestinal
268406
268406
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm1: paracetamol rectal suppositories 40 mg/kg single dose
(1 tab = 325 mg) immediately postoperation.
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Intervention code [1]
258076
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Treatment: Drugs
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Comparator / control treatment
Arm2: placebo made from fat soluble parafin identical in appearance with paracetamol rectal suppository, single dose, immediately postoperation
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Control group
Placebo
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Outcomes
Primary outcome [1]
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postoperative pain in abdominal hysterectomy using questionnaires and visual analog scale (VAS)
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Assessment method [1]
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Timepoint [1]
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at 6 months after randomization
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Secondary outcome [1]
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Adverse effects such as nausea vomiting, fever using questionnaire
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Assessment method [1]
273269
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Timepoint [1]
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at 6 months after randomization
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Secondary outcome [2]
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Opioids consumption using medical records
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Assessment method [2]
297339
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Timepoint [2]
297339
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at 6 months after randomization
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Eligibility
Key inclusion criteria
Elective benign abdominal hysterectomy
Age <70 years
Body weight 30-80 kg
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Minimum age
20
Years
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Maximum age
70
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
paracetamol hypersensitivity
Bleeding disorders
Had underlying diseases
Renal, hepatic dysfunction
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes were used
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated the sequence number
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
None
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3216
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Thailand
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State/province [1]
3216
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Khon Kaen
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Khon Kaen Hospital
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Address [1]
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Srichan Road
Muang
Khon Kaen
40000
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Country [1]
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Thailand
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Primary sponsor type
Hospital
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Name
Khon Kaen Hospital
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Address
Srichan Road
Muang
Khon Kaen
40000
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Country
Thailand
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Secondary sponsor category [1]
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Individual
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Name [1]
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Tanyalak Wongluecha
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Address [1]
257674
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Srichan Road
Muang
Khon Kaen
40000
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Country [1]
257674
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Thailand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260507
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Khon Kaen Hospital Ethics Committee
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Ethics committee address [1]
260507
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Srichan Road
Muang
Khon Kaen
40000
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Ethics committee country [1]
260507
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Thailand
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Date submitted for ethics approval [1]
260507
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01/08/2010
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Approval date [1]
260507
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19/08/2010
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Ethics approval number [1]
260507
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78/01/2553
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Summary
Brief summary
Paracetamol in conjunction with strong opioids such as morphine shown to reduce the amount of opioid used and improve analgesic effect. Paracetamol has many available forms such as oral injection and suppository. In the first 24 hours after surgery, women were not allowed to have any ingestion, except intravenous solution. Therefore, paracetamol rectal suppository was add with strong opioids (morphine or pethidine) routinely postoperative painkillers for postoperative pain relief. The aims of adding paracetamol rectal suppository were to reduce opioids consumption and avoid their adverse effects, e.g. nausea and/or vomiting, orthostatic hypotension and respiratory compression. We therefore would like to study the effectiveness and safety of paracetamol rectal suppository in pain reduction in women undergoing total abdominal hysterectomy. We hypothesized that paracetamol rectal suppository can reduce postoperative pain in abdominal hysterectomy more effective than placebo. The primary outcome was postoperative pain score and the secondary outcome was volume of opioids consumption.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
32246
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Phone
32246
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Fax
32246
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Email
32246
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Contact person for public queries
Name
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Tanyalak Wongluecha
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Address
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Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000
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Country
15493
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Thailand
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Phone
15493
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+6643336789 ext 3736
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Fax
15493
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+6643336789 ext 3736
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Email
15493
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[email protected]
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Contact person for scientific queries
Name
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Naroemit Wonglikitpunya
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Address
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Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000
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Country
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Thailand
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Phone
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+6643336789 ext 3736
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Fax
6421
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+6643336789 ext 3736
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Email
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[email protected]
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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.
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