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Trial registered on ANZCTR


Registration number
ACTRN12613000692730
Ethics application status
Approved
Date submitted
12/06/2013
Date registered
25/06/2013
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is analgesia required for grommet insertion?
Scientific title
Do children undergoing grommet insertion require analgesia to reduce post operative pain?
Secondary ID [1] 282639 0
nil
Universal Trial Number (UTN)
U1111-1141-4880
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain associated with Myringotomy and Grommet insertion for chronic / recurrent otitis media 289340 0
Condition category
Condition code
Ear 289678 289678 0 0
Other ear disorders
Anaesthesiology 289755 289755 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A) * Paracetamol + Ibuprofen oral suspension (group receiving analgesia).
* Placebo liquid oral suspension (group not receiving analgesia)
B) Dose of paracetamol (20mg/kg) and ibuprofen (10mg/kg) based on individual childs weight. Dose of placebo will be in equivalent volume of liquid as they would receive if they were getting ibuprofen and paracetamol
C) Dose frequency is one dose preoperatively. (excluding any rescue analgesia which is available to all children in both groups after their operation as needed)
D)Oral suspension
E) The duration of the intervention and its follow-up is 1 day

Intervention code [1] 287306 0
Other interventions
Comparator / control treatment
1. Children undergoing grommet insertion (who meet selection criteria) who receive a placebo mixture instead of Paracetamol plus ibuprofen prior to surgery
2. Fluid thickener: Modified maize starch (E1442), maltodextrin, tara gum, xanthan gum, guar gum. (Dietitian approved)
3. Oral suspension

Control group
Placebo

Outcomes
Primary outcome [1] 289765 0
Primary outcome measure: Pain levels (Wong-Baker Pain Scale) in the ear(s) after surgery
Timepoint [1] 289765 0
Two pain scores will be routinely recorded: one 90min post surgery and the other just prior to discharge home from recovery (2-4hours on average after the operation). Further pain scores will be taken prior to any rescue analgesia if required.
Secondary outcome [1] 303199 0
1. Rescue analgesic requirements in the peri-operative unit after the operation. This will only be done if the child is assessed to be in pain postoperatively. If at any stage after the operation, regardless of the group the child is in, if the child is in distress a pain score will be taken. If the child is in pain then appropriate analgesia will be given. The amount of rescue analgesia needed will be collated.
Timepoint [1] 303199 0
1. Two pain scores will be routinely recorded: one 90min post surgery and the other just prior to discharge home from recovery (2-4hours on average after the operation). Further pain scores will be taken prior to any rescue analgesia if required.
Secondary outcome [2] 303353 0
Pain in throat from intubation/laryngeal mask airway. If possible all children will be ventilated with bag mask ventilation and no airway device will be used. Hence this outcome measure only applies to children who recieved the above airway adjuncts. When the pain score is obtained (using the Wong-Baker Pain Scale) the child will be asked to locate their pain and if it is in their throat it will be assumed this is due to the airway adjunct and not their grommet procedure.
Timepoint [2] 303353 0
Two pain scores will be routinely recorded: one 90min post surgery the other just prior to discharge home from recovery(2-4hours on average after the operation). Further pain scores will be taken prior to any rescue analgesia if required
Secondary outcome [3] 303354 0
Pain from IV cannulae. If possible all children will not be cannulated. Hence this outcome measure only applies to children who it was found necessary to have a IV cannula insitu. When the pain score is obtained (using the Wong-Baker Pain Scale) the child will be asked to locate their pain and if it is around their cannula site it will be assumed this is due to the IV cannula and not their grommet procedure.
Timepoint [3] 303354 0
Two pain scores will be routinely recorded: one 90min post surgery the other just prior to discharge home from recovery(2-4hours on average after the operation). Further pain scores will be taken prior to any rescue analgesia if required

Eligibility
Key inclusion criteria
All children age 3-16 undergoing unilateral or bilateral grommet insertion.
Minimum age
3 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:
- A child with irritable and uncooperative behaviour (e.g. Attention Deficit Hyperactivity Disorder).
- A child with cognitive impairment.
- Presence of acute ear pain
- Presence of ear infection.
- When other operations (e.g. Adenoidectomy) is performed at the same time.
- Patient having a synchronous pain from a site other than the ears.

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)
We will be recruiting patients planned for grommet insertion at the pre-operative assessment. An explanation regarding the study will be given to them (or carer/guardian). They will also be given the study information sheet.

Consent forms are available at the time to be completed if they feel ready to give their consent. If not, when they come for their surgery they can let us know whether they wish to participate in the study. If required we may also call the parent/guardian at home to answer any questions they may have.

Sealed envelope will be used to deliver the randomization to the point of intervention. The anaesthetist will open the envelop to determine the grouping of the participant, just before the patient is anaesthetized for their grommet operation to ensure adequate allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sampling method: Consecutive sampling of every patient who are being listed for grommet insertion according to our inclusion and exclusion criteria and then Block randomisation will be employed
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
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Participant’s information will be collected on paper initially and subsequently tabulated and analysed using the statistical software SPSS (version 17.0)

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] 5131 0
New Zealand
State/province [1] 5131 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 287418 0
Self funded/Unfunded
Name [1] 287418 0
Address [1] 287418 0
Country [1] 287418 0
New Zealand
Primary sponsor type
Individual
Name
Dr Ben McHale
Address
10 Regent Street
Springfield
Rotorua
3015
Country
New Zealand
Secondary sponsor category [1] 286167 0
None
Name [1] 286167 0
Address [1] 286167 0
Country [1] 286167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289396 0
Health and Disability Ethics Commitee of New Zealand
Ethics committee address [1] 289396 0
Ministry of Health (New Zealand)
No 1 The Terrace
PO Box 5013
Wellington
New Zealand

Ethics committee country [1] 289396 0
New Zealand
Date submitted for ethics approval [1] 289396 0
Approval date [1] 289396 0
27/05/2013
Ethics approval number [1] 289396 0
13/NTA/63

Summary
Brief summary
Title of Project: Do children undergoing grommet insertion require analgesia?

Brief Description of the Purpose of the Project:
The opinion of pain experienced by children after Grommet insertion varies from no pain to mild or moderate pain. During the operation the amount of pain relief given to a child varies from none to three classes of analgesia. We plan to conduct a triple blinded randomized controlled trial to determine whether analgesia is required during the operation to prevent early post-operative pain.

Hypothesis: There is no difference in the pain levels between children who did and did not receive intra-operative analgesia.
Trial website
Trial related presentations / publications
McHale B, Badenhorst CD, Low C, Blundell D. Do children undergoing bilateral myringotomy with placement of ventilating tubes benefit from pre-operative analgesia? A double-blinded, randomised, placebo-controlled trial. J Laryngol Otol 2018; 1–8. https://doi.org/10.1017/ S0022215118001111
Public notes

Contacts
Principal investigator
Name 40614 0
Dr Ben McHale
Address 40614 0
10 Regent Street
Springfield
Rotorua
3015
Country 40614 0
New Zealand
Phone 40614 0
+64 276997693
Fax 40614 0
Email 40614 0
bhmchale@gmail.com
Contact person for public queries
Name 40615 0
Dr Dr Ben McHale
Address 40615 0
Rotorua Hospital
Lakes district health board
Arawa street
Rotorua
Country 40615 0
New Zealand
Phone 40615 0
+64 07 348 1199
Fax 40615 0
Email 40615 0
bhmchale@gmail.com
Contact person for scientific queries
Name 40616 0
Dr Dr Ben McHale
Address 40616 0
Rotorua Hospital
Lakes district health board
Arawa street
Rotorua
Country 40616 0
New Zealand
Phone 40616 0
+64 07 348 1199
Fax 40616 0
Email 40616 0
bhmchale@gmail.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