Peritonsillar Infiltration With Levobupivacaine for Posttonsillectomy Pain
Peritonsillar Infiltration With Levobupivacaine for Relief of Posttonsillectomy Pain: Does Concentration Have Any Effect?
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to recurrent infections leading to obstructive symptoms
- Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to tonsillar hypertrophy leading to obstructive symptoms.
Exclusion Criteria:
- Hypersensitivity to sevoflurane, benzodiazepine, fentanyl analogues, propofol and components, paracetamol, levobupivacaine
- Presence of coagulation disorders and chronic diseases
- Presence of regular use of analgesics
- Presence of analgesic use within 24 hours prior to surgery
- Presence of upper respiratory system infection
- Inability to understand the pain scales, being unable to communicate.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Group S
Preincisional bilateral peritonsillar infiltration of a total of 6 mL of saline
|
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.
Altri nomi:
|
|
Comparatore attivo: Group LL
Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.25% (3 mL to each tonsil).
|
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.
Altri nomi:
|
|
Comparatore attivo: Group HL
Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.5% (3 mL to each tonsil).
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in postoperative pain
Lasso di tempo: 24 hours
|
pain assessed with FPRS (Faces pain rating scale)
|
24 hours
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Presence of dysphagia
Lasso di tempo: 24 hours
|
number of participants with dysphagia and without dysphagia.
|
24 hours
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: K.Sanem Cakar Turhan, Specialist, Ankara University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 134-3866
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .