Vol 44 # 2 June 2012 - Kma.org.kw

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121 KUWAIT MEDICAL JOURNAL June 2012 Original Article Determining the Effect of Sufentanil on Propofol Injection Pain Tuba Berra Saritas, Hale Borazan, Inci Kara, Sema Tuncer, Seref Otelcioglu Department of Anesthesiology and Reanimation, Selcuk University Meram Medical School, Konya, Turkey Kuwait Medical Journal 2012; 44 (2): 121 - 124 ABSTRACT Objectives: Propofol is a general anesthetic. Its most important disadvantage is pain on injection. Our aim was to evaluate the effectiveness of sufentanil on propofol injection pain (PIP). Design: Case control randomized double-blind study Setting: Anesthesia department of Selcuk University Meram Medical School , Turkey Subjects: A total of 160 adults, 18 to 65 years, ASA I-II patients, scheduled for operations under general anesthesia, were enrolled in this study. A 22-gauge intravenous (IV) catheter was inserted into a vein on the dorsum of the hand. Patients were randomly allocated to one of four groups to receive either saline or 0.5, 1, 2 mcg sufentanil in 2 ml volume. Thirty seconds after the intravenous (IV) injection of the pretreatment drug, 5 ml of 1% propofol at room temperature (Fresenius Kabi, Hamburg, Germany) was injected IV at rate of 0.5 ml/sec. Pain was assesed verbally and scored as none (0), mild (1), moderate (2), severe (3). Interventions: Prior injection of sufentanil or placebo Main Outcome Measures: Severity of PIP Results: Demographic data were comparable among four groups. Sufentanil at 1 and 2 mcg doses significantly decreased pain incidence when compared to the saline group (p < 0.05). Sufentanil 0.5 mcg had no effect (p > 0.05). Although 2 mcg sufentanil decreased the incidence of PIP more than 1 mcg, there was no significant difference between these groups (p > 0.05). Conclusion: Sufentanil at one and 2 mcg doses reduced the incidence and severity of PIP KEY WORDS: general anesthesia, pain, propofol, sufentanil INTRODUCTION Propofol is a frequently used intravenous (IV) anesthetic for induction of anesthesia and for sedation in daycase surgery. The most important disadvantage of propofol is injection pain, which is reported in 28 - 90% of patients [1] . Many different methods have been proposed to reduce the incidence and severity of this adverse effect of propofol. Pretreatment with alfentanil [2] , use of fentanyl [3] , local anesthetics [4] , metoclopramide [5] , tramadol [6] , ketamine [7] , ondansetron [8] , addition of lidocaine [9,10] , alfentanil [11] ephedrine [12] , granisetron [13] , and injection of propofol into a large antecubital vein or into a freely flowing intravenous (IV) line, are the techniques described for prevention of propofol injection pain (PIP) . Fentanyl, remifentanil, alfentanil and sufentanil can provide analgesia and assist anesthetic effects when used as presurgical medication, induction or maintenance agents, for postsurgical pain relief and neurolept and neuroleptanalgesia and as supplements to regional anesthesia. Opioids are also reported to be effective in preventing PIP [3,10,11] . Sufentanil is a selective μ receptor agonist, 5-10 times more effective analgesic than fentanyl and with a high safety [14] . However, there are few studies in literature that report sufentanil analgesic effect on PIP. In this study we tried to evaluate effectiveness of sufentanil, in prevention of PIP. SUBJECTS AND METHODS Ethics Committee approval was obtained from Selcuk University Meram Medical Faculty. All patients gave their informed and written consent. A total of 160 adult, aged between 18 to 65 years, ASA physical status I-II patients, scheduled for operations under general anesthesia, were enrolled into this randomized, double-blind study conducted in 2006 at the anesthesiology department of Meram Medical School of Selcuk University. Patients with Address correspondence to: Tuba Berra Saritas, MD, Associate Professor, Selcuk University Meram Medical School, Department of Anesthesiology and Reanimation, Konya,Turkey. Tel: 90 3322236166, Fax: 90 3322236181, E-mail:erdemtugba@hotmail.com
June 2012 KUWAIT MEDICAL JOURNAL 122 a history of neurologic or psychiatric disease, difficulty with communication, analgesic and / or sedative administration, history of renal or hepatic insufficiency, thrombophlebitis and hypersensitivity to the study drugs were excluded from the study. On patient arrival in the operating room without any premedication, a 22-gauge intravenous (IV) catheter was inserted into a vein on the dorsum of the hand. Patients were monitored with electrocardiography, pulse oximetry (oxygen saturation), and non-invasive blood pressure. All infusion fluids were 0.9% normal saline at a rate of 500 ml/h. The study subjects were randomly allocated to one of four groups to receive either saline, 0.5, 1 or 2 mcg sufentanil in 2 ml volume. Thirty seconds after the intravenous (IV) injection of the pretreatment drug, 5 ml of 1% propofol at room temperature (Fresenius Kabi, Hamburg, Germany) was injected IV at a rate of 0.5 ml/sec. Pain was assesed verbally and scored as none (0), mild (1), moderate (2) and severe (3). Any spontaneous complaints of pain were noted. If there were no spontaneous complaints, patients were asked about pain 30 seconds after the propofol injection. Observations were noted by an independent observer. Induction of anesthesia was performed in all patients with propofol upto 2.5 mg/kg, 0.6 mg/ kg atracurium and 1 - 2 mcg sufentanil. Anesthesia was maintained with nitrous oxide 50% and sevoflurane 2 - 2.5% in oxygen. Any excitation during induction and reactions such as hypotension, nausea, vomiting or flushing were recorded. Statical analysis Statistical analysis was carried out using SPSS for WINDOWS software program version 15.0 (SPSS, Chicago, IL). The Mann Whitney-U test was used to analyze the results of the patients’ subjective assessment of pain. A p-value less than 0.05 was considered statistically significant. Differences between scores from the saline group and the other groups were estimated as 1.5 and with a 0.05 α error Table 1: Characteristics of the patients (mean ± SD) Patient Group 1 Group 2 Group 3 Group 4 Characteristics Sex (F/M) ASA I/II Age Weight (kg) Status of Pain No Pain Pain 17/23 21/19 37.8 ± 12.05 70.2 ± 11.03 Group 1 % 7.5 92.5 21/19 19/21 38.4 ± 13.10 70.7 ± 12.08 Group 2 % 5 95 19/21 20/20 34.08 ± 12.06 70.97 ± 11.05 Group 3 % 22.5 77.5 * 18/22 21/19 33.03 ± 11.04 70.55 ± 12.7 (two- sided) the required sample size was 40 per group yielding a power higher than 90%. RESULTS The study included 160 patients. Demographic data were comparable among four groups (Table 1). The patients did not experience any pain or discomfort during study drug injection. The overall pain incidence was 92.5% in the saline group and 70% in all study groups. When we compared the saline group and sufentanil groups, sufentanil Table 2: Distribution according to reported pain by the patient *p < 0.05 compared to Group 1 and 2 ** p < 0.05 compared to Group 1 and 2 Group 4 % 55 45 ** decreased PIP incidence significantly (p < 0.05). Pain incidence was 95% in 0.5 mcg sufentanil group, 77.5% in 1 mcg sufentanil group and 45% in 2 mcg sufentanil group. Sufentanil at 1 and 2 mcg doses significantly decreased PIP incidence when compared to the saline group (p < 0.05, Table 2). 0.5 mcg sufentanil had no effect on PIP incidence (p > 0.05, Table 2). Although 2 mcg sufentanil decreased PIP incidence much more than 1 mcg group, the difference was not significant (p > 0.05). Moderate and severe pain incidence was 2-8 (5 - 20%) in Group 3 and 4-4 (10%-10%) in Group 4. It was significantly decreased when compared to Group 1 and 2 (p < 0.05, Table 3). Table 3: Distribution of the patients according to intensity of the pain Intensity of pain Group 1 (N = 40) n (%) Group 2 (N = 40) n (%) Group 3 (N = 40) n (%) Group 4 (N = 40) n (%) No Pain (VAS 0) Mild Pain(VAS 1) Moderate Pain(VAS 2) Severe Pain(VAS 3) 3 ¥ (7.5) 6 (15.0) 12 (30.0) 19 (47.5) 2 ¥€ (5.0) 11 (27.5) 14 (35.0) 13 (32.5) 19* (47.5) 11 (27.5) 8* ¥ (20.0) 2 € (5.0) 22** (55.0) 10 (25.0) 4 ¥¥ (10.0) 4 €€ (10.0) *p < 0.05 compared to Group 1 and 2, ** p < 0.05 compared to Group 1 and 2, *¥ p < 0.05 compared to Group 1 and 2, ¥¥ p < 0.05 compared to Group 1 and 2, € p < 0.05 compared to Group 1 and 2, €€p < 0.05 compared to Group 1 and 2, ¥ p < 0.05 compared to Group 3 and 4, ¥€ p < 0.05 compared to Group 3 and 4
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