None listed
Conditions
Brief summary
Tonsil surgery is one of the most common childhood surgical procedures, however the postoperative recovery is often long and challenging for children and their families. Opioids are a common analgesic following tonsil surgery, and although effective, they have notable side effects including respiratory depression, nausea and vomiting and constipation. This study aims to explore if clonidine can provide comparable, non-opioid pain management to oxycodone for post-operative pain following tonsillotomy.
Interventions
Following informed written parental consent, paediatric patients, aged 3– 8 years, undergoing tonsillotomy surgery will be randomised to receive either oral clonidine (2mcg/kg 6-hourly pro re nata (PRN)) or standard care (oral Oxycodone 1mg/ml) solution for breakthrough pain as required analgesia for 10 weight adjusted doses total as an adjunct therapy to the standard treatment (regular paracetamol and Ibuprofen up to 7 days as prescribed by treating team) provided postoperatively and after disc
Following informed written parental consent, paediatric patients, aged 3– 8 years, undergoing tonsillotomy surgery will be randomised to receive either oral clonidine (2mcg/kg 6-hourly pro re nata (PRN)) or standard care (oral Oxycodone 1mg/ml) solution for breakthrough pain as required analgesia for 10 weight adjusted doses total as an adjunct therapy to the standard treatment (regular paracetamol and Ibuprofen up to 7 days as prescribed by treating team) provided postoperatively and after discharge. Post- Post anaesthesia care unit (PACU) discharge for those in the clonidine group, clonidine will be their first line as required medication for pain. There will be active follow up with the families to ensure study adherence. All families are provided with a standard diary to document medication administration following tonsillectomy surgery. Our families will also be provided with a study diary where they will document further information. They will also report this in the study database via survey links sent daily.
Sponsors
Perth Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
Children aged 3 to 8.99 years undergoing elective surgery under general anaesthesia for tonsillotomy +/- adenoidectomy +/- grommets +/- EUA or cautery of inferior turbinates.
Exclusion criteria
Currently taking clonidine or guanfacine medication. Known cardiovascular, respiratory or neurological disorders giving an ASA III or above status. Known hypersensitivity to the active substance or to any of the excipients listed. Language barriers impeding data collection. Department for Child Protection and Family Support is involved in their care. Planned admissions to the Paediatric Intensive Care Unit (PICU). Any concern in the ability of the parents/guardian or child to appropriately adhere to the study protocol or any issues which, in the investigator’s opinion, would increase the risks of study participation to the child.
Outcome results
None listed