Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators aimed to evaluate the effects of different concentrations of preincisional peritonsillar levobupivacaine (0.25% ve 0.5%) on postoperative pain and bleeding
72 ASA I-II patients between 3 and 12 years of age who scheduled to undergo tonsillectomy were enrolled in this randomized, prospective and placebo-controlled study. The indications for tonsillectomy were recurrent infections and tonsillar hypertrophy leading to obstructive symptoms.
The patients included to the study were randomly assigned to one of the 3 groups to receive different concentrations of levobupivacaine or saline.
The mean arterial pressure (MAP) and heart rates (HR) of all patients were recorded during the whole anesthesia and surgical procedures. The duration of anesthesia and surgery were also recorded. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.
During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group S | Placebo Comparator | Preincisional bilateral peritonsillar infiltration of a total of 6 mL of saline |
|
| Group LL | Active Comparator | Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.25% (3 mL to each tonsil). |
|
| Group HL | Active Comparator | Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.5% (3 mL to each tonsil). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group S | Other | Peritonsillar infiltration with saline Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value. During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postoperative pain | pain assessed with FPRS (Faces pain rating scale) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of dysphagia | number of participants with dysphagia and without dysphagia. | 24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| K.Sanem Cakar Turhan, Specialist | Ankara University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25912590 | Derived | Cakar Turhan KS, Salviz EA, Beton S, Timuroglu ST, Catav S, Ozatamer O. Peritonsillar infiltration with levobupivacaine for posttonsillectomy pain relief: does concentration have any effect? A double-blind randomized controlled clinical study. Eur Rev Med Pharmacol Sci. 2015 Apr;19(7):1276-84. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Group LL | Drug | Peritonsillar infiltration with low-dose of levobupivacaine 0.25%. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value. During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour. |
|
|
| Group HL | Drug | Peritonsillar infiltration with high dose of levobupivacaine 0.5%. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value. During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour. |
|
|
| D017670 |
| Sodium Compounds |