None listed
Conditions
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.
Interventions
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 ope
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
Sponsors
Dr Ben McHale
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
All children age 3-16 undergoing unilateral or bilateral grommet insertion.
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.
Outcome results
None listed