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Trial registered on ANZCTR


Registration number
ACTRN12616000672459
Ethics application status
Approved
Date submitted
26/04/2016
Date registered
23/05/2016
Date last updated
23/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of intravenous pre-emptive versus postoperative paracetamol on postoperative nausea and vomiting in patients undergoing strabismus surgery: A prospective randomised study
Scientific title
The effect of intravenous pre-emptive versus postoperative paracetamol on postoperative nausea and vomiting in children undergoing strabismus surgery: A prospective randomised study
Secondary ID [1] 289072 0
None
Universal Trial Number (UTN)
U1111-1182-2705
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative nausea and vomiting 298519 0
strabismus surgery 298520 0
Condition category
Condition code
Anaesthesiology 298603 298603 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective randomised study was approved by the Ethics Committee of Ataturk University, Medical Faculty, Erzurum, Turkey. Ninety-six patients, between the ages of 2 and 14 years, ASA (the classification of the American Society of Anesthesiologists) physical status I-II who underwent elective strabismus surgery under general anaesthesia were included. Written informed consent was obtained from the parents.
Basic data including patients’ age, weight and height were recorded. All patients were pre-medicated with midazolam (0.5 mgkg-1, orally) before the procedure of anaesthesia. Before transfer to the operating room, patients were randomly divided into 3 equal groups (n=32): In the preemptive paracetamol group (n = 32), IV infusion of paracetamol 15 mgkg-1 (1.5 mlkg-1) (Perfalgan Registered Trademark, Bristol-Myers Squibb, France) was administered one hour before operation over 20 minutes and IV infusion of saline (1.5 ml kg-1) administered at recovery room after full consciousness. Patients in the postoperative paracetamol group (n = 32) received IV infusion of saline (1.5 ml kg-1) one hour before operation over 20 minutes and paracetamol postoperatively at recovery room after full consciousness at the same dose as the preemptive paracetamol group. A standardized general anaesthesia regimen was provided for all patients enrolled in the study. Standard monitoring including non-invasive arterial pressure, electrocardiography and pulse oximetry was established in the operating room. General anesthesia was induced with propofol 3–5 mgkg-1 and lidocaine 0.1 mgkg-1 and a laryngeal mask airway (LMA) was inserted. Maintenance of anaesthesia was achieved with sevoflurane 2–3% and N2O/O2 (FiO2, 50%). At the end of the surgery, LMA was removed and patients were transferred to the post-anaesthesia recovery room. Intravenous metoclopramide 0.15 mgkg-1 were used in case of two or more vomiting episodes. The number of the orbital muscles requiring surgery, duration of anaesthesia, duration of surgery, the number of patients who experienced oculocardiac reflex (OCR) requiring treatment with atropine were recorded. In the recovery room, an independent observer blinded to the group assignment recorded the pain score, complaints of nausea and vomiting, the need for rescue analgesics and the need for antiemetic drug during 24 hours postoperatively. Nausea was defined as only retching and vomiting was defined as a forceful expulsion of the gastric contents through the mouth or the nose.
Postoperative pain condition during the first 24 hours was evaluated using the Faces Pain Scale. This scale includes six faces reflecting the severity of pain and every facial expression has a numerical score. The selected face by the children or their parents and the numerical score of selected face was recorded. In control group, postoperative analgesia was provided with oral Ibuprofen suspension 5 mgkg-1 (IbufenRegistered Trademark, Abbott, Istanbul, Turkey) in the event of Faces Pain Scale score greater than or equal to 3. In preemptive and postoperative paracetamol groups, postoperative analgesia was provided with oral paracetamol suspension 5 mgkg-1 (CalpolRegistered Trademark, GlaxoSmithKline, Istanbul, Turkey) in the event of Faces Pain Scale score greater than or equal to 3.
Intervention code [1] 294580 0
Treatment: Drugs
Comparator / control treatment
Control group (n = 32): patients received IV infusion of saline (1.5 ml kg-1) pre- and postoperatively. Postoperative analgesia was provided with oral Ibuprofen suspension 5 mgkg-1 (Ibufen Registered Trademark, Abbott, Istanbul, Turkey) in the event of Faces Pain Scale score greater than or equal to 3.
Control group
Placebo

Outcomes
Primary outcome [1] 298101 0
The primary outcome of the study was the incidence of nausea during the first 24 hours postoperatively. Nausea defined as retching and it was assessed by self-report by child in symptom diary.
Timepoint [1] 298101 0
postoperative 0-6, 6-12 and 12-24 hours.
Primary outcome [2] 298304 0
The primary outcome of the study was the incidence of vomiting during the first 24 hours postoperatively. Vomiting was defined as a forceful expulsion of the gastric contents through the mouth or the nose. and it was assessed by self-report by child in symptom diary.
Timepoint [2] 298304 0
Postoperative 0-6, 6-12 and 12-24 hours.
Secondary outcome [1] 323180 0
the need for rescue analgesic during 24 hours postoperatively via reviewing of medical records.
Timepoint [1] 323180 0
Postoperative 0-6, 6-12 and 12-24 hours.
Secondary outcome [2] 323459 0
the need for antiemetic requirement during 24 hours postoperatively via reviewing of medical records.
Timepoint [2] 323459 0
postoperative 0-6, 6-12, 12-24 hours.
Secondary outcome [3] 323460 0
Faces Pain Scale score via reviewing of medical records.
Timepoint [3] 323460 0
Every hour whilst awake from arrival in recovery room to 24 hours post-operatively.

Eligibility
Key inclusion criteria
Ninety-six patients, between the ages of 2 and 14 years,ASA (the classification of the American Society of Anesthesiologists) physical status I-II who underwent elective strabismus surgery under general anaesthesia were included
Minimum age
2 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of allergy to any of the study medications (general anesthetic agents or paracetamol), with a history of previous PONV or motion sickness, hepatic or renal disease, use of antiemetic, antihistaminic, analgesic or corticosteroid 24 hours prior to surgery and were excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Thirty patients in each group were needed to demonstrate a mean difference of 20% for the nausea incidence between two study groups with a power of 80% and alpha 5%.
Data were analysed using SPSS software 12.0 (SPSS Inc., Chicago, IL, USA) and calculated as mean +/- standard deviation or number (%), p<0.05 was considered significant. Distribution of data was assessed using the Kolmogorov-Smirnov test. Comparisons among groups were done with one-way ANOVA test. Fisher’s exact test was used to compare the percentage values.

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] 7836 0
Turkey
State/province [1] 7836 0
Erzurum

Funding & Sponsors
Funding source category [1] 293451 0
Self funded/Unfunded
Name [1] 293451 0
Address [1] 293451 0
Country [1] 293451 0
Primary sponsor type
Individual
Name
Mehmet AKSOY
Address
Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
postcode: 25240
Country
Turkey
Secondary sponsor category [1] 292273 0
Individual
Name [1] 292273 0
Ilker INCE
Address [1] 292273 0
Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
postcode:25240
Country [1] 292273 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294898 0
Ethics Committee of Ataturk University, Medical Faculty, Erzurum, Turkey
Ethics committee address [1] 294898 0
Ethics Committee of Ataturk University, Medical Faculty, Erzurum, Turkey
postcode:25240
Ethics committee country [1] 294898 0
Turkey
Date submitted for ethics approval [1] 294898 0
20/01/2014
Approval date [1] 294898 0
23/01/2014
Ethics approval number [1] 294898 0
1

Summary
Brief summary
Strabismus surgery is a common ophthalmic surgical procedure in children. Postoperative nausea and vomiting (PONV) are undesirable postoperative outcomes, occurring in up to 88% of patients undergoing strabismus surgery. Primary purpose of this prospective randomized study was to compare the efficacy of pre-emptive versus postoperative paracetamol on PONV in children undergoing strabismus surgery. Also, we researched the effect of preemptive and postoperative paracetamol administration on postoperative analgesia quality and total analgesic consumption after strabismus surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47414 0
Dr Mehmet AKSOY
Address 47414 0
Department of Anesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
postcode: 25240
Country 47414 0
Turkey
Phone 47414 0
+905058193526
Fax 47414 0
Email 47414 0
drmaksoy@hotmail.com
Contact person for public queries
Name 47415 0
Dr Mehmet AKSOY
Address 47415 0
Department of Anesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
postcode: 25240
Country 47415 0
Turkey
Phone 47415 0
+905058193526
Fax 47415 0
Email 47415 0
drmaksoy@hotmail.com
Contact person for scientific queries
Name 47416 0
Dr Ilker INCE
Address 47416 0
Department of Anesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
postcode: 25240
Country 47416 0
Turkey
Phone 47416 0
+905534705222+
Fax 47416 0
Email 47416 0
ilkerince1983@yahoo.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