None listed
Conditions
Brief summary
Using chilled saline as a medium for Coblation has been shown to reduce post-operative pain in both paediatric and adult extracapsular tonsillectomy. Its effect on the more minimally invasive intracapsular tonsillectomy (ICT) is unknown. A double-blind randomised controlled trial was performed to identify the effect of chilled saline on operation length, intra/post-operative bleeding, post-operative pain and return to normal activity in paediatric Coblation ICT.
Interventions
Participants were randomised to either room temperature or chilled saline and underwent intracapsular tonsillectomy (ICT) +/- adenoidectomy via an Evac 70 Coblation wand, for a total procedure time around 15 minutes. Saline was used as the medium for coblation intraoperatively.
Patients meeting clinical indications for ICT were recruited through the Ear, Nose and Throat (ENT) surgeon's clinic and subsequently surgeries were performed by the same ENT surgeon. Post-operatively patients were prov
Participants were randomised to either room temperature or chilled saline and underwent intracapsular tonsillectomy (ICT) +/- adenoidectomy via an Evac 70 Coblation wand, for a total procedure time around 15 minutes. Saline was used as the medium for coblation intraoperatively. Patients meeting clinical indications for ICT were recruited through the Ear, Nose and Throat (ENT) surgeon's clinic and subsequently surgeries were performed by the same ENT surgeon. Post-operatively patients were provided a questionnaire to assess postoperative pain, bleeding and return to normal activity and this was returned at the follow up appointment two weeks following surgery. Arm 1: 0.9% Room Temperature Saline with temperature of 22.5°C (comparator) Arm 2: 0.9% Chilled Saline with temperature of 3.8°C (intervention)
Sponsors
Prof. Simon Carney - Adelaide Specialist Group, Flinders Private Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Those with clinical indication for ICT, specifically sleep disordered breathing with grade 3 or 4 tonsillar hyperplasia.
Exclusion criteria
Patients with a history of anaemia and disorders of haemostasis, velopharyngeal insufficiency, patients with significant craniofacial abnormalities or tongue hypertrophy, previous peri-tonsillar abscess, tonsillotomy performed due to suspicion of malignancy, contraindications to post-surgical analgesia protocol, history of general anaesthetic risk,, and patients on pre-surgery analgesics or other pain-altering medications.
Outcome results
None listed