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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
Scientific title
Paracetamol Rectal Suppository for postoperative pain reduction in Abdominal Hysterectomy A Randomized controlled trial
Secondary ID [1] 259644 0
none
Universal Trial Number (UTN)
U1111-1119-5401
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy woman and no underlying disease 261210 0
Condition category
Condition code
Renal and Urogenital 259361 259361 0 0
Other renal and urogenital disorders
Oral and Gastrointestinal 268406 268406 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1: paracetamol rectal suppositories 40 mg/kg single dose
(1 tab = 325 mg) immediately postoperation.
Intervention code [1] 258076 0
Treatment: Drugs
Comparator / control treatment
Arm2: placebo made from fat soluble parafin identical in appearance with paracetamol rectal suppository, single dose, immediately postoperation
Control group
Placebo

Outcomes
Primary outcome [1] 262173 0
postoperative pain in abdominal hysterectomy using questionnaires and visual analog scale (VAS)
Timepoint [1] 262173 0
at 6 months after randomization
Secondary outcome [1] 273269 0
Adverse effects such as nausea vomiting, fever using questionnaire
Timepoint [1] 273269 0
at 6 months after randomization
Secondary outcome [2] 297339 0
Opioids consumption using medical records
Timepoint [2] 297339 0
at 6 months after randomization

Eligibility
Key inclusion criteria
Elective benign abdominal hysterectomy
Age <70 years
Body weight 30-80 kg
Minimum age
20 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
paracetamol hypersensitivity
Bleeding disorders
Had underlying diseases
Renal, hepatic dysfunction

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)
Sealed opaque envelopes were used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated the sequence number
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3216 0
Thailand
State/province [1] 3216 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 258537 0
Hospital
Name [1] 258537 0
Khon Kaen Hospital
Address [1] 258537 0
Srichan Road
Muang
Khon Kaen
40000
Country [1] 258537 0
Thailand
Primary sponsor type
Hospital
Name
Khon Kaen Hospital
Address
Srichan Road
Muang
Khon Kaen
40000
Country
Thailand
Secondary sponsor category [1] 257674 0
Individual
Name [1] 257674 0
Tanyalak Wongluecha
Address [1] 257674 0
Srichan Road
Muang
Khon Kaen
40000
Country [1] 257674 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260507 0
Khon Kaen Hospital Ethics Committee
Ethics committee address [1] 260507 0
Srichan Road
Muang
Khon Kaen
40000
Ethics committee country [1] 260507 0
Thailand
Date submitted for ethics approval [1] 260507 0
01/08/2010
Approval date [1] 260507 0
19/08/2010
Ethics approval number [1] 260507 0
78/01/2553

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32246 0
Address 32246 0
Country 32246 0
Phone 32246 0
Fax 32246 0
Email 32246 0
Contact person for public queries
Name 15493 0
Tanyalak Wongluecha
Address 15493 0
Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000
Country 15493 0
Thailand
Phone 15493 0
+6643336789 ext 3736
Fax 15493 0
+6643336789 ext 3736
Email 15493 0
Tanyalak_54@hotmail.com
Contact person for scientific queries
Name 6421 0
Naroemit Wonglikitpunya
Address 6421 0
Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000
Country 6421 0
Thailand
Phone 6421 0
+6643336789 ext 3736
Fax 6421 0
+6643336789 ext 3736
Email 6421 0
Tanyalak_54@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary