Introduction
Day-case surgery  (ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope)is of great value to patients and the health service. It has rapidly expanded as a cost-effective and resource-conserving surgical intervention. However, the ability to (ENT surgical (Operation,surgery,operating) microscope)deliver a safe and cost-effective general anesthetic with minimal side effects and rapid recovery is demanded in a day-case(ENT surgical (Operation,surgery,operating) microscope) surgery unit. Pain and emesis are the two major complaints after day case surgery. Opioids are the agents of choice for severe pain. However, this class of analgesics is associated with dose-dependent adverse effects such as PONV, (ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope)sedation, respiratory depression, resulting in delayed discharge or prolonged hospital stay. (ENT surgical (Operation,surgery,operating) microscope)Non-opioid analgesics, e.g. acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), are often used alone or as adjuncts to opioids because of fewer adverse effects compared to opioids alone. However, NSAIDs also have side effects [1]. Lornoxicam is a new NSAID that belongs chemically to oxicams, a chemical class including piroxicam and tenoxicam. Lornoxicam is a potent inhibitor of cyclo-oxygenase and the only oxicam with a 15 times shorter half-life than piroxicam and tenoxicam [2](ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope). In addition, lornoxicam can be given by I.V. route. (ENT surgical (Operation,surgery,operating) microscope)Lornoxicam has a better safety profile than diclofinac and naproxen with regards to renal and hepatic function tests. In addition to better GIT tolerability compared to selective COX2 inhibitors;(ENT surgical (Operation,surgery,operating) microscope) it is completely metabolized to inactive metabolites [2,3]. Lornoxicam has been successfully used in prevention and treatment of postoperative pain. However, evaluation of the perioperative analgesic efficacy of lornoxicam in day-case surgery has not yet been studied. This randomized, double blinded study was designed to compare the quality of perioperative analgesia as well as side effects of IV lornoxicam versus fentanyl in (ENT surgical (Operation,surgery,operating) microscope)patients scheduled for minor to moderate day-case ENT surgical(ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope) procedures.
Materials and Methods:
(ENT surgical (Operation,surgery,operating) microscope)Male or female patients (aged 18-60 yr) were eligible for inclusion in the study. After obtaining the approval of the Hospital Research & Ethical Committee and patient’s informed consent, patients were randomized into three groups of ASA class I and II, scheduled to undergo minor to moderate day-case ENT surgical(ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope,) procedures e.g. tonsillectomy, excision of ENT(ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope) lesion (e.g. vocal cord nodules and cysts), polypectomy and endoscopic sinus operations were enrolled in this randomized, double blinded study between May and December 2008. (ENT surgical (Operation,surgery,operating) microscope)Exclusion criteria were patients with body mass index (BMI) > 30%, drug or alcohol abuse, and known allergy to NSAIDs, paracetamol or any contraindications for opioid use.
The protocol was similar for all patients. Prior to surgery, patients were educated in the use of the 10 – point visual analog scale (VAS) for pain assessment (0 = no pain to 10 = maximum pain). No premedication was given. In the holding area, an IV cannula was inserted (ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope)and an IV infusion of Lactated Ringer’s was started. HR, MAP and SpO2 were recorded before induction (baseline value). Since (ENT surgical (Operation,surgery,operating) microscope)fentanyl is a clear fluid while lornoxicam is yellow, the pharmacist prepared, covered and coded the medications in two coded envelopes for each patient. One envelope containing lornoxicam 8mg (L8), 16 mg (L16) or placebo to be given half an hour before induction of anesthesia and another envelope with fentanyl 100 µg (F) or placebo to be given with induction i.e. each (ENT surgical (Operation,surgery,operating) microscope)patient received either IV (F), (L8) or (L16).The medications were administered by a different anesthetist, who was not involved in the study. Anesthesia was induced with propofol 2 mg/kg IV followed by cisatracurium 0.15 mg/kg IV to facilitate orotracheal intubation. After tracheal intubation, the patients were ventilated to normocapnia with sevoflurane (2-3% end tidal) in 50% oxygen in air. All patients received IV 1 gm of paracetamol after induction and were monitored with ECG, MAP, SpO2 and EtCO2(ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope).
Supplementary fentanyl 0.5 µg/kg was given IV as required in all groups (if > 20% increases in MAP or HR than preinduction values in presence of adequate muscle relaxation). At the end of surgery, muscle relaxation was reversed and extubated. In the post-anaesthesia care unit (PACU), the time from extubation to spontaneous eye opening was compared between the groups. The patients(ENT surgical (Operation,surgery,operating) microscope) were monitored with ECG(ENT surgical (Operation,surgery,operating) microscope), SpO2, MAP, respiratory rate (RR), VAS and sedation score (0 =awake, 1=mild sedation, 2=sleepy but arousable, and 3 = very sleepy) at 0.5,1, 2, 3 and 4 hours by an anaesthetist, who was not aware of the study drug used.
Intramuscular (IM) injection of meperidine 1 mg/kg was administered as a rescue analgesic at VAS > 4. The total amount of meperidine required during first 4 hrs postoperative was recorded(ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope). The time of the study drugs injection was recorded after decoding their codes. The first need for rescue analgesic was recorded as the time from the administration of the study-drug and the administration of meperidine. The incidence of PONV or any adverse event was recorded. The PACU staff was not aware of the study drug given(ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope).
The results were analyzed using SPSS version 16. Sample size was 35 patients for each group in order to detect a 20% change in HR and MAP. (ENT surgical (Operation,surgery,operating) microscope)The α-error was assumed to be 0.05 and the type II error was set at 0.20. Numerical data were expressed as mean ± SD. The groups were compared with analysis of variances (ANOVA). The VAS pain scores were analyzed by Mann-Whitney U test(ENT surgical (Operation,surgery,operating) microscope). Categorical data were compared using the Chi square test. P value of 0.05 was used as the level of significance(ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope).
Results
105 patients (ENT surgical (Operation,surgery,operating) microscope)aged between 18 and 52 yr were enrolled in the study. There were no significant demographic differences between groups (Table 1).
HR and MAP were(ENT surgical (Operation,surgery,operating) microscope) significantly higher at 10 and 20 minutes after induction of anaesthesia in group L8 compared to groups F and L16 (P < 0.05) (Fig. 1,2). The number of patients with inadequate intra-operative analgesia was significantly higher in group L8 compared to groups F and L16 (Fig 3). In PACU, 40 minutes postoperatively, HR, MAP and VAS were significantly higher in groups F and L8 (Fig 4,5,6). (ENT (ear-nose-throat department，Otolaryngology) surgical (Operation,surgery,operating) microscope)The first analgesic requirement time was significantly longer in group L16 compared to groups F and L8 (Table 2). The mean sedation scores in PACU were insignificantly higher in groups F and L8 compared to group L16 (Table1). While the incidence(ENT surgical (Operation,surgery,operating) microscope) of PONV was significantly higher in groups F and L8 (p<0.05) (Table 1).
http://www.bjmp.org/content/analgesia-day-case-ent-surgery-efficacy-lornoxicam