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Peritonsillar Infiltration With Levobupivacaine for Posttonsillectomy Pain

NCT02322346 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-12-23

No results posted yet for this study

Summary

The investigators aimed to evaluate the effects of different concentrations of preincisional peritonsillar levobupivacaine (0.25% ve 0.5%) on postoperative pain and bleeding

Conditions

Interventions

OTHER

Group S

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.

DRUG

Group LL

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.

DRUG

Group HL

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.

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Principal Investigators

  • K.Sanem Cakar Turhan, Specialist · Ankara University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-12-31
Completion
2008-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02322346 on ClinicalTrials.gov