ANZCTR - Registration

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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]

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

Condition category

Condition code

Ear

Other ear disorders

Anaesthesiology

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]

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]

Primary outcome measure: Pain levels (Wong-Baker Pain Scale) in the ear(s) after surgery

Timepoint [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 [1]

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]

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]

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]

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]

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]

Eligibility

Key inclusion criteria

All children age 3-16 undergoing unilateral or bilateral grommet insertion.

Minimum age

3 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

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

1/07/2013

Actual

8/10/2013

Date of last participant enrolment

Anticipated

Actual

31/07/2014

Date of last data collection

Anticipated

Actual

31/07/2014

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Bay of Plenty

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Dr Ben McHale

Address

10 Regent Street
Springfield
Rotorua
3015

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Commitee of New Zealand

Ethics committee address [1]

Ministry of Health (New Zealand)
No 1 The Terrace
PO Box 5013
Wellington
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

27/05/2013

Ethics approval number [1]

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

Dr Ben McHale

Address

10 Regent Street
Springfield
Rotorua
3015

Country

New Zealand

Phone

+64 276997693

Fax

bhmchale@gmail.com

Contact person for public queries

Name

Dr Ben McHale

Address

Rotorua Hospital
Lakes district health board
Arawa street
Rotorua

Country

New Zealand

Phone

+64 07 348 1199

Fax

bhmchale@gmail.com

Contact person for scientific queries

Name

Dr Ben McHale

Address

Rotorua Hospital
Lakes district health board
Arawa street
Rotorua

Country

New Zealand

Phone

+64 07 348 1199

Fax

bhmchale@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	Do children undergoing bilateral myringotomy with placement of ventilating tubes benefit from pre-operative analgesia? A double-blinded, randomised, placebo-controlled trial.	2018	https://dx.doi.org/10.1017/S0022215118001111

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically