Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001203741
Ethics application status
Approved
Date submitted
30/10/2013
Date registered
4/11/2013
Date last updated
4/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pre-emptive intravenous ketorolac analgesia does not alter the risk of bleeding after tonsillectomy in children
Scientific title
the preoperative use of intravenous ketorolac analgesia does not alter the risk of bleeding after tonsillectomy in children.
Secondary ID [1] 283481 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the use of non-steroidal anti-inflammatory drugs for post-tonsillectomy analgesia in children 290399 0
Condition category
Condition code
Anaesthesiology 290790 290790 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
children scheduled for tonsillectomy with or without adenoidectomy were randomized to receive a slow IV infusion over 15 min of either Ketorolac 1mg kg -1, after induction of anesthesia.
Intervention code [1] 288192 0
Treatment: Drugs
Comparator / control treatment
the control treatment was a slow IV infusion over 15 min of Paracetamol 15 mg kg-1, after induction of anesthesia.
Control group
Active

Outcomes
Primary outcome [1] 290785 0
The primary outcome measures was the difference between the two groups as regards the hemoglobin level. Hemoglobin (Hb) level was measured in the laboratory as a part of the routine preoperative preparation for tonsillectomy at the hospital. Additionally, non-invasive hemoglobin level (SpHb) was assessed at the same time when blood was drawn from the child for the routine preoperative laboratory investigations, using a multi-wavelength pulse oximetry.SpHb measurement was assessed on arrival at the post anesthesia care unit (PACU) and repeated at 12h, 24h postoperatively and another measurement was obtained at the 7th postoperative day.
Timepoint [1] 290785 0
the 7th postoperative day
Secondary outcome [1] 305285 0
the difference between the two groups as regards the pain scores ., pain intensity was assessed by an anesthesiologist, blinded to the treatment group using an objective pain score (OPS) immediately upon PACU admission, then 30min, 1h, 2h, 4h, and 6h postoperatively. This OPS took into account the child’s blood pressure, crying, movement and agitation, with each variable scoring 0–2 points (best to worst).
Timepoint [1] 305285 0
6h postoperatively
Secondary outcome [2] 305305 0
The incidence of postoperative vomiting
Timepoint [2] 305305 0
24h after surgery

Eligibility
Key inclusion criteria
ASA physical status I children scheduled for tonsillectomy with or without adenoidectomy. All patients enrolled in this study had normal blood counts, with normal coagulation profile (prothrombin time, activated partial thromboplastin time, platelet count, and bleeding time.
Minimum age
2 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included the use of paracetamol or NSAIDs within 6 h or any other analgesic medication within 12 h before surgery, and a known allergy to any of the study drugs.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
The required sample size was calculated using the G*Power(copyright) software version 3.1.0 (Institut fur Experimentelle Psychologie, Heinrich Heine Universitat, Dusseldorf, Germany).
The primary outcome measures were the difference between the two groups as regards the pain scores and hemoglobin level. It was estimated that a sample of 70 patients per group would have a power of 82% to detect a medium effect size (d) of 0.5 as regards the outcome measures using a two-sided U test and setting the type I error at 0.05.
Data were analyzed on a personal computer using the IBM(copyright) SPSS(copyright) Statistics version 21 (IBM(copyright)Corp., Armonk, NY, USA). The Shapiro-Wilk test was used to test the normality of numerical data distribution.
Normally distributed data were presented as mean (SD) and the unpaired t test was used for intergroup comparisons. Skewed data were presented as median (interquartile range) and the Mann-Whitney U test was used to compare between-group differences. For comparison of paired skewed data, the Wilcoxon signed ranks test was used. Repeated measures analysis of variance (ANOVA) was used to compare differences among serial measures.
Categorical data were presented as ratio or as number (percentage) and differences between the two groups were compared using the chi square test or Fisher’s exact test, when appropriate.
P < 0.05 is considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2011
Actual
10/12/2011
Date of last participant enrolment
Anticipated
Actual
18/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
147
Accrual to date
Final
Recruitment outside Australia
Country [1] 5546 0
Saudi Arabia
State/province [1] 5546 0
eastern province

Funding & Sponsors
Funding source category [1] 288187 0
Hospital
Name [1] 288187 0
king Abdulaziz Naval Base Hospital.
Country [1] 288187 0
Saudi Arabia
Primary sponsor type
Hospital
Name
king Abdulaziz Naval Base Hospital.
Address
king Abdulaziz Naval Base , Jubail, 31951
Country
Saudi Arabia
Secondary sponsor category [1] 286912 0
None
Name [1] 286912 0
Address [1] 286912 0
Country [1] 286912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290097 0
Hospital Ethics and research Committee
Ethics committee address [1] 290097 0
Ethics committee country [1] 290097 0
Saudi Arabia
Date submitted for ethics approval [1] 290097 0
01/11/2011
Approval date [1] 290097 0
12/11/2011
Ethics approval number [1] 290097 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43958 0
A/Prof Waleed M. Abdelmageed
Address 43958 0
king Abdulaziz Naval Base Hospital , Jubail, 31951,PO Box:413
Country 43958 0
Saudi Arabia
Phone 43958 0
+966 55 7189366
Fax 43958 0
Email 43958 0
[email protected]
Contact person for public queries
Name 43959 0
Waleed M. Abdelmageed
Address 43959 0
king Abdulaziz Naval Base Hospital , Jubail, 31951,PO Box:413
Country 43959 0
Saudi Arabia
Phone 43959 0
+966 55 7189366
Fax 43959 0
Email 43959 0
[email protected]
Contact person for scientific queries
Name 43960 0
Waleed M. Abdelmageed
Address 43960 0
king Abdulaziz Naval Base Hospital , Jubail, 31951,PO Box:413
Country 43960 0
Saudi Arabia
Phone 43960 0
+966 55 7189366
Fax 43960 0
Email 43960 0
[email protected]

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.