Levobupivacaine and Levobupivacaine+Adrenalin in Pediatric Tonsillectomy Operations.
Comparison of The Perioperative and Postoperative Effects of Levobupivacaine and of Levobupivacaine+Adrenaline in Pediatric Tonsillectomy: A Double-Blind Randomized Study
Selcuk University Medical Faculty
88 participants
May 1, 2015
Interventional
Conditions
Summary
Tonsillectomy is among the most frequently performed surgical procedures for commonly seen occlusive and recurrent infections in otolaryngology. Patients frequently complain of pain on swallowing after this operation. Various tonsillectomy studies have shown the advantage of local anaesthetic (LA) injection, which often is performed before procedures to prevent pain stimulus during the operation . In our study, we primarily aimed to assess the effects of levobupivacaine and of levobupivacaine + adrenaline administered during tonsillectomy on postoperative pain and secondarily on nausea and vomiting, amount of bleeding, time to first oral intake and quality of oral intake, time to first analgesic request, and total amount of analgesics consumed until the time of discharge.
Eligibility
Inclusion Criteria1
- Scheduled patients between the ages of five and twelve for pediatrictonsillectomy.
Exclusion Criteria1
- Patients who were known to be allergic to the drugs used in the study; patients with bleeding disorders or liver, kidney, cardiac, or lung diseases; patients more than 35 kg (potentially obese or having sleep apnea); patients who used antiemetics, analgesics, steroids, or antihistamines 24 hours before the operation; patients for whom the drugs used in the study were contraindicated; patients who returned for treatment of bleeding or any other complication after the operation; or patients whose parents did not consent to their participation in the study were excluded.
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Interventions
A total of 90 American Society of Anaesthesiologists class 1 or 2 (ASA I-II) patients between the ages of five and twelve participated in the study. After anaesthetic induction and before the operation, the patients were divided into groups. Levobupivacaine only (0.5%) 0.4 mg.kg-1 for group L (n=45), levobupivacaine (0.5%) 0.4 mg.kg-1+adrenaline (1:200.000) for group LA (n=45) were prepared for each tonsillar fossae. For each tonsillar fossae, 2.5 ml of the solution was injected as a withering and swollening submucosal infiltration in sterile conditions to the inferior and superior poles and to all areas surrounding the plicae of both tonsillar fossae by the otolaryngologist, who did not know which group was receiving which treatment. Anaesthesia was maintained by using 50% O2+ 50% N2O and 2% sevoflurane. The period between the placement of the mouth retractor for the operation and the removal of the mouth retractor after bleeding was controlled was recorded as the duration of the surgery. The perioperative amount of bleeding was deduced by measuring the aspirator apparatus and the swabs used and calculating the weight of the physiological saline solution before and after the operation. Cautery and suture use for the patients also were recorded. The patients were monitored in the postanesthesia care unit (PACU) postoperatively. The parents were taken into the PACU to decrease postoperative anxieties that the children might feel because they were in an unfamiliar environment. If present, diplopia, hallucination, cough, facial paralysis, vocal cord paralysis, bronchospasm, and postoperative bleeding were recorded as postoperative complications. At the end of the operation, the follow-up was taken over by an anaesthesiologist who did not know the study groups. In this way, the double-blind study protocol was maintained. Postoperatively, at the 10th, 30th, and 60th minutes and the 6th, 12th, and 24th hours, the pain scores of the patients were assessed by using the Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS), and nausea and vomiting were assessed by measuring postoperative nausea and vomiting (PONV:0 = no nausea or vomiting; 1= nausea but no vomiting; 2 = vomited once in 30 minutes; 3 = two or more episodes in 30 minutes). The modified Aldrete score (MAS) was used as a recovery criterion, and a MAS greater than 8 was considered to indicate recovery. For patients with a CHEOPS score greater than 6, pain treatment was conducted with intravenous asetaminofen within the first 6 hours and oral asetaminofen after the first 6 hours at a dose of 10 mg.kg.h-1. The time to the first analgesic request and the total amount of analgesic administered were recorded. If the PONV score was higher than 3, patients were treated with 150 µg.kg-1 of metoclopramide intravenously.
Locations(1)
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ACTRN12617001167358