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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Active Comparator | Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils. |
|
| Sodium chloride | Placebo Comparator | Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Topical administration of bupivacaine via gauze swab in the tonsillar fossae after removal of throat tonsils. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until 6 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until 6 days postoperatively |
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Inclusion Criteria:
All patients undergoing isolated tonsillectomy from the age of 5 years to 40 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin S Berg, MD PhD | Nordlandssykehuset HF | Principal Investigator |
| Erik W Nielsen, MD PhD | Nordlandssykehuset HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordland Hospital | Bodø | N-8096 | Norway |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Sodium chloride | Drug | Topical administration of 0,9% sodium chloride via gauze swab in the tonsillar fossae after removal of throat tonsils. |
|
|
| 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 | 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 | 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 | 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 | 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 | Until 6 days postoperatively |
| Difference in defined daily doses of morphine in the two groups | 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 | Until one hour postoperatively |
| Difference in hours of nausea | Until 6 days postoperatively |
| Difference in the number of times eaten solid food | Until 6 days postoperatively |
| Number of vomiting episodes | Until 6 days postoperatively |
| Number of episodes in which blood is spit for more than 30 minutes from 1 hour postoperatively | Until 6 days postoperatively |
| Hours with measured fever> = 38 C rectally, tympanometric or with temporal scanner | Until 6 days postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |