Can local anaesthesia in the throat after removal of throat tonsils reduce pai
Phase 1
- Conditions
- ocal pain after tonsillectomy, both at rest and during swallowing. Assessed by self-reporting at 1, 2, 3, 4, 5, 6 hours and 1,2,4 and 6 days after surgery.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2020-002862-15-NO
- Lead Sponsor
- ordland Hospital. Bodø. Dep of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
All patients undergoing isolated tonsillectomy from the age of 5 years and older.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
Exclusion Criteria
Patients using opioids regularly.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to investigate whether patients who get bupivacaine on the gauze swab used for hemostasis after tonsillectomy has less pain the first hours and days postoperatively compared to patients that have physiological saline solution (placebo). ;Secondary Objective: Another objective is to measure blood concentration of bupivacaine after this topical administration of bupivacaine.;Primary end point(s): Self-reported pain at rest and during swallowing indicated by the numerical rating scale for patients aged 10 years and older, and indicated by the faces pain scale-revised for patients aged 5-10 years old.;Timepoint(s) of evaluation of this end point: Pain is registered at 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Need for additional pain-killers, nausea, vomiting, reduced apetite.<br>2. Blood concentration of bupivacaine;Timepoint(s) of evaluation of this end point: 1. 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively.<br>2. Pilot study including 2 patients, with frequent blood sampling (every 15 minutes until 90 minutes) to find the three optimal time-points for blood sampling in the whole cohort.