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Trial registered on ANZCTR


Registration number
ACTRN12613000435785
Ethics application status
Approved
Date submitted
12/04/2013
Date registered
17/04/2013
Date last updated
17/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of analgesic efficacy of intravenous paracetamol and intravenous dexketoprofen trometamol in multimodal analgesia after hysterectomy
Scientific title
Intravenous usage of paracetamol and dexketoprofen trometamol for analgesia after hysterectomy procedures in females
Secondary ID [1] 282310 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Illnesses which can be treated by performing hysterectomy(abnormal menstrual bleeding, endometriosis, myomas, adenomiyosis) 288851 0
Treating pain which was caused by hysterectomy operation 288852 0
Condition category
Condition code
Anaesthesiology 289194 289194 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1-1 gr of paracetamol (Perfalgan 10mg/ml 100 ml Flacon Bristol-Myers Squibb Labarotories, Renaudin Itxassou France) administered to 20 patients (Group I) by intravenous infusion in 15 minutes during the closure, and 1 gr of intravenous paracetamol administered at every 6 hours during the following 24 hours postoperatively.Paracetamol was not dilueted, as it is produced as a solution and marketing in bottles of 100ml.
ARM 2-Dexketoprofen trometamol 50 mg/2 mL (Arveles 50 mg/2 ml Menarini International Italy) diluted in 100 mL of saline and administered to 20 patients(Group II), in 15 minutes by intravenous infusion during the closure and dose repeated at every 8 hours during the following 24 hours of postoperative period.After surgery, patient controlled analgesia equipment (Abbott Pain Management Provider, Abbott Laboratories, North Chicago, IL, USA) will be provided to every patient enrolled in this trial (60 patients) as resuce analgesia. It will be programmed for a bolus dose of 1mg of morphine then locked for 10 minutes (morphine concentration is 0.2mg /ml).
The follow up period of the study was 24 hours as we evaluated acute postoperstive pain control
Intervention code [1] 286922 0
Treatment: Drugs
Comparator / control treatment
100 ml of saline was administered to 20 patients (Group III, control group)by intravenous infusion in 15 minutes during the closure and at every 6 hours for the following 24 hours of post-operative period.
Control group
Placebo

Outcomes
Primary outcome [1] 289302 0
Primary outcome1:To compare by means of differences in cumulative 24-hour morphine consumption among groups. 24 hour morphine consumption was recorded automatically by patient controlled analgesia device as total morphine concentration, total volume of the solution and necessary volume giving after demand was programmed before.
Timepoint [1] 289302 0
Primary timepoint:24 hours at the postoperative period. Evaluated at 0th, 1st, 2nd, 4th, 8th, 12th, 16th, 20th, and 24th hours of postoperative period.
Primary outcome [2] 289303 0
Primary outcome 2: Pain scores of the patients. Evaluated by using Visual analogue scale(VAS).
Timepoint [2] 289303 0
Primary timepoint 2:24 hours at the postoperative period. Evaluated at 0th, 1st, 2nd, 4th, 8th, 12th, 16th, 20th, and 24th hours of postoperative period.
Primary outcome [3] 289304 0
Primary oucome 3: Side affects of the drugs(nausea, vomiting,itching etc.) They all evaluated by using verbal discriptive scale as 0= none, 1=mild, 2=moderate,3= severe
Timepoint [3] 289304 0
Primary timepoint 3: Postoperative 24 hours. Evaluating at 0th, 1st, 2nd, 4th, 8th, 12th, 16th, 20th, and 24th hours of postoperative period.
Secondary outcome [1] 302193 0
Secondary outcome 1:Mean arterial pressures
During the operation (5 minutes interval) and and at 0th, 1st, 2nd, 4th, 8th, 12th, 16th, 20th, and 24th hours of postoperative period. During the operation patients were monitorerd by using a monitor which measured noninvasive blood pressure and automatically showed sistolic blood pressure, diastolic blood pressure and mean arterial pressure in 5 minutes interval continually. Same kind monitor was used in the postoperative period at certain times(0th, 1st, 2nd, 4th, 8th, 12th, 16th, 20th, and 24th hours) in gynecology clinic
Timepoint [1] 302193 0
Secondary timepoint 1:During the operation and 24 hours of postoperative period
Secondary outcome [2] 302295 0
Secondary outcome 2: Heart rate
During the operation (5 minutes interval) and and at 0th, 1st, 2nd, 4th, 8th, 12th, 16th, 20th, and 24th hours of postoperative period. Electrocardiography(ECG) monitorisation was performed during the operation and at the postoperative period and heart rate (beat/minute) was recorded.
Timepoint [2] 302295 0
Secondary timepoint 2:During the operation and 24 hours of postoperative period
Secondary outcome [3] 302296 0
Secondary outcome 3:Ramsay Sedation Score. Evaluated by using Ramsay Sedation Scale:
1 Patient is anxious and agitated or restless, or both
2 Patient is co-operative, oriented, and tranquil
3 Patient responds to commands only
4 Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
5 Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
6 Patient exhibits no response
0th, 1st, 2nd, 4th, 8th, 12th, 16th, 20th, and 24th hours of postoperative period
Timepoint [3] 302296 0
Secondary Timepoint 3:24 hours of postoperative period

Eligibility
Key inclusion criteria
Patients prepared for total abdominal hysterectomy operation,without severe renal, hepatic and cardiac disease, peptic ulcus and gastrointestinal bleeding, crohn’s disease or colitis ulcerosa, coagulation disorder, known allergic reaction to one of these drugs, chronic pain and routine analgesic usage, occurrence of complication during the operation were included into the study
Minimum age
20 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe renal, hepatic and cardiac disease, peptic ulcus and gastrointestinal bleeding, crohn’s disease or colitis ulcerosa, coagulation disorder, known allergic reaction to the study drugs, chronic pain and routine analgesic usage, occurrence of complication during the operation were excluded.

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)
Allocation was concealed by using a sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was performed using computer- generated block random.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary aim of this study was to compare by means of differences in cumulative 24-hour morphine consumption among groups. A total sample size of 57 (19 per group) was required to detect at least 15.5 mg difference between any of two groups with a power of 90% at the 5% significance level. The difference of 15.5 mg was taken from literature. 6 Sample size estimation was performed by using NCSS and PASS 2000 software.
Normal distribution of continuous variables was assessed by Shapiro Wilk test. Significance of differences between groups was analyzed with One Way Analysis of Variances for means and with Kruskal Wallis for medians. Nominal data were evaluated by Pearson’s Chi-Square test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5008 0
Turkey
State/province [1] 5008 0
Ankara

Funding & Sponsors
Funding source category [1] 287071 0
Hospital
Name [1] 287071 0
Ministry of Health Ankara Training and Research Hospital
Country [1] 287071 0
Turkey
Primary sponsor type
Individual
Name
Hulya Basar
Address
Chief of Anaesthesia and Reanimation Department Ministry of Health Ankara Training and Research Hospital Sukriye mahallesi Ulucanlar caddesi No:89 06340 Altindag/Ankara
Country
Turkey
Secondary sponsor category [1] 285846 0
Individual
Name [1] 285846 0
Turkay Cakan
Address [1] 285846 0
Specialist in Anaesthesiology
Anaesthesia and Reanimation Department
Ministry of Health Ankara Training and Research Hospital Sukriye mahallesi Ulucanlar caddesi No:89 06340 Altindag/Ankara
Country [1] 285846 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289087 0
Local Ethics Committee of Ministry of Health Ankara Training and Research Hospital
Ethics committee address [1] 289087 0
Ministry of Health Ankara Training and Research Hospital Sukriye Mahallesi Ulucanlar Caddesi No:89 06340 Altindag/Ankara
Ethics committee country [1] 289087 0
Turkey
Date submitted for ethics approval [1] 289087 0
Approval date [1] 289087 0
24/02/2009
Ethics approval number [1] 289087 0
00263/2009-121

Summary
Brief summary
We aimed to evaluate analgesic efficacy, opioid-sparing and opioid-related adverse effects of iv paracetamol and iv dexketoprofen trometamol in combination with iv morphine after abdominal hysterectomy. Double-blinded, randomized, placebo controlled, prospective study was designed.Sixty ASA I-II patients scheduled for abdominal hysterectomy were enrolled to study. Patients were randomly divided into three groups as paracetamol, dexketoprofen trometamol and placebo (0.9% NaCl). Intravenous patient-controlled analgesia morphine was used as a rescue analgesic in all groups. Pain scores, hemodynamic parameters, morphine consumption, patient satisfaction and side effects were evaluated.
Normal distribution of continuous variables was assessed by Shapiro Wilk test. Significance of differences between groups was analyzed with One Way Analysis of Variances for means and with Kruskal Wallis for medians. Nominal data were evaluated by Pearson’s Chi-Square test.
Visual Analog Scale (VAS) scores weren’t statistically significantly different among the groups in all evaluation times, but decrease in VAS scores was statistically significant after the evaluation at 12th hour in all groups. Total morphine consumption (morphine concentration=0.2mg/ml) in group paracetamol (72.3+/-38.0 ml) and dexketoprofen trometamol (69.3+/- 24.1 ml) was significantly lower than group placebo (129.3+/- 22.6 ml).
Conclusions: Dexketoprofen trometamol and paracetamol didn’t cause significant change on pain scores but increased patients’ comfort. Although total morphine consumption was significantly decreased by both drugs, side effects were similar among the groups.
According to results of the present study routine addition of dexketoprofen trometamol and paracetamol to PCA morphine after hysterectomies is not recommended.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39182 0
A/Prof Hulya Basar
Address 39182 0
Ministry of Health Ankara Training and Research Hospital Anaesthesiology and Reanimation Department Sukriye mahallesi Ulucanlar caddesi No:89 06340 Altindag/ Ankara
Country 39182 0
Turkey
Phone 39182 0
+ 90 312 595 31 80
Fax 39182 0
Email 39182 0
[email protected]
Contact person for public queries
Name 39183 0
Turkay Cakan
Address 39183 0
Ministry of Health Ankara Training and Research Hospital Anaesthesiology and Reanimation Department Sukriye mahallesi Ulucanlar caddesi No:89 06340 Altindag/ Ankara
Country 39183 0
Turkey
Phone 39183 0
+ 90 312 5953175
Fax 39183 0
Email 39183 0
[email protected]
Contact person for scientific queries
Name 39184 0
Turkay Cakan
Address 39184 0
Ministry of Health Ankara Training and Research Hospital Anaesthesiology and Reanimation Department Sukriye mahallesi Ulucanlar caddesi No:89 06340 Altindag/ Ankara
Country 39184 0
Turkey
Phone 39184 0
+ 90 312 5953175
Fax 39184 0
Email 39184 0
[email protected]

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