A Phase 3 interventional study of Bupivacaine and Sodium chloride in Pain, Postoperative, sponsored by Nordlandssykehuset HF. Completed at 1 site in Norway. Open to participants aged 5 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-08-04.
Sponsored by Nordlandssykehuset HF · Phase 3, Interventional, and Treatment
A placebo-controlled and double-blind study is planned according to current legislation and ICH GCP guidelines with 80 patients at Nordland Hospital, Bodø. Fifty percent are randomized to receive bupivacaine 5 mg / ml on the gauze swabs used to stop the bleeding after tonsillectomy, and 50% receive 0.9% sodium chloride.
Pain at rest and pain when swallowing according to numerical rating scale (0-10), as well as the presence of the following symptoms (yes / no): nausea, vomiting, food intake, bleeding, fever, need for extra painkillers in the form of morphine or similar will be registered 1, 2, 3, 4, 5, 6 hours and 1, 2 4 and 6 days after the operation. Differences are analyzed with "mixed models" statistics and the results will be published in a peer-based journal.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 84 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Nordlandssykehuset HF is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
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All patients undergoing isolated tonsillectomy from the age of 5 years to 40 years
Exclusion Criteria:
Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils.
Drug: Bupivacaine
Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils.
Drug: Sodium chloride
Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils.
Also known as: Marcain
Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils.
Also known as: Saline
Difference in self-reported pain at rest.
Difference in self-reported pain at rest by the numerical rating scale (0-10, 0 = no pain, 10 worst pain) for patients aged 10 years and older, and indicated by the faces pain scale-revised (0-10, 0 = no pain, 10 worst pain) for patients aged 5-10 years old, on average over all measurement times. Pain is registered at 1,2,3,4,5 and 6 hours.
Time frame: Until 6 hours postoperatively.
Difference in pain when swallowing on average over all measurement times.
Difference in pain according to the numerical rating scale (0-10, 0 = no pain, 10 worst pain) between the two groups when swallowing on average over all measurement times. Pain is registered at 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively.
Time frame: Until 6 days postoperatively
Graphic Descriptive representation of numerical rating scale (0-10, 0 = no pain, 10 worst pain) in a curve diagram
Pain is registered at 1,2,3,4,5 and 6 hours, and 1,2,4 and 6 days postoperatively
Time frame: Until 6 days postoperatively
Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) at rest between the groups day 1 after the operation
Time frame: Until 1 day postoperatively
Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) at rest between the groups day 6 after the operation
Time frame: Until 6 days postoperatively
Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) when swallowing between the groups day 1 after the operation
Time frame: Until 1 day postoperatively
Difference in numerical rating scale (0-10, 0 = no pain, 10 worst pain) when swallowing between the groups day 6 after the operation
Time frame: Until 6 days postoperatively
Difference in defined daily doses of morphine in the two groups
Time frame: Until 6 days postoperatively
Difference in number and type a) serious adverse event, b) serious adverse reaction and c) adverse reaction where the adverse reaction is an adverse medical event where there is a probable or possible association with the test preparation
Time frame: Until one hour postoperatively
Difference in hours of nausea
Time frame: Until 6 days postoperatively
Difference in the number of times eaten solid food
Time frame: Until 6 days postoperatively
Number of vomiting episodes
Time frame: Until 6 days postoperatively
Number of episodes in which blood is spit for more than 30 minutes from 1 hour postoperatively
Time frame: Until 6 days postoperatively
Hours with measured fever> = 38 C rectally, tympanometric or with temporal scanner
Time frame: Until 6 days postoperatively
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Nordlandssykehuset HF