An Evaluation of Analgesic Efficacy and Clinical Acceptability of Intravenous Tramadol: METHODS

In: Anesthesia

26 Oct 2009

Forty-five healthy male or female patients aged 18-55 years scheduled to undergo surgical removal of an impacted mandibular third molar were eligible for participation in the study (see Table 1 for demographic data). All patients required bone removal and suturing. Exclusion criteria were as follows: pregnancy or lactation; use of anticoagulants, analgesics, or any central nervous system depressants; hypersensitivity to opioids or any other medication likely to interfere with the study drugs. Treatment with any analgesic whatsoever was forbidden for 24 hours prior to surgery. Ethical approval was obtained from the Hospital and University Ethical Committee and written informed consent from all the patients involved in the study.

At a presurgery visit, patients were evaluated for inclusion, and baseline assessments (including a medical history) were performed. Patients were randomly allocated before surgery according to a computer-generated randomization list to 1 of the 2 treatment groups. generic cialis online

Thus, 45 ASA status 1 dental outpatients undergoing elective surgical removal (with bone removal and tooth extraction) of 1 impacted third molar under local anesthesia, were allocated by randomization to 2 groups of 22 (group A) and 23 (group B) patients each (n = 45). Neither group had received any premedication beforehand. One of the authors (JAR) had recently found that tramadol drops 1.5 mgAg before multiple dental extractions in children aged 4-7 years resulted in significantly better analgesia for up to 120 minutes postoperatively. As the absolute oral bioavailability of tramadol drops is 70.6 (1.13)%, it was decided that Group A (T/P) receive intravenous tramadol 1.5 mgAg injected over 2 minutes, followed by a bolus dose of intravenous propofol 0.4 mgAg. Maintenance consisted of a continuous infusion of propofol 3 mgAg A, with an additional bolus dose of 0.4 mgAg intravenously 2-3 minutes prior to the infiltration of the local anesthetic solution.

Group В (P/P) patients received no tramadol but instead a saline placebo solution and an identical amount of propofol. The study was blinded by means of a saline placebo solution with identical packaging to the tramadol and only the particular patient’s number as identifier. All treatments were carried out by the same anesthesiologist and the same maxillo-facial surgeon, and all assessments by a single research nurse. In both groups, 2-3 minutes after the propofol bolus, 4 mL of mepiv-acaine 2% was injected appropriately in all patients to provide local anesthesia. Ten minutes after the completion of effective local anesthetic blockade (as assessed by numbness of the mucous membranes to pin pricks), the surgical procedure was started.

Monitoring consisted of a Dinamap adult/pediatric noninvasive blood pressure monitor, an Ohmeda Biox IIIR pulse oximeter for measuring oxygen saturation, and a continuous electrocardiogram. Blood pressures (systolic, diastolic, mean), pulse and respiratory rates, oxygen saturations, and anxiety scores (observed scale: 1 = very anxious; 2 = alert, moderately anxious, 3 = calm, indifferent, not anxious) were recorded at the following time intervals: before the start of sedation, 15 minutes after the propofol bolus and start of the infusion but before the start of the surgery, and at the end of the procedure. Make your pharmacy dollar go further and buy viagra uk online

Sedation scores (according to Ramsay et al were 1 = fully awake, orientated; 2 = drowsy; 3 = eyes closed, arousable to command; 4 = eyes closed, arousable to shoulder shaking; 5 = unarousable to shoulder-tip shaking) were assessed at the following time intervals: before the start of sedation, 15 minutes after the propofol bolus and start of the infusion but before the start of the surgery, and at the end of the procedure.

Postoperative pain scores were performed by the pa¬tients filling in visual analogue scales (VAS; marking on a continuous line of 10 cm with 0 = no pain; 10 = intolerable pain) at the following time intervals after surgery: 1, 2, 3, and 4 hours (in the recovery room) and at 6, 8, and 10 hours (at home). If any patients experienced pain between 2-10 hours postoperatively, escape analgesia was provided as oral tramadol 50-100 mg (1 to 2 capsules) every 4 hours. Time to escape analgesia was recorded.
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The pegboard test was used as a measure of recovery following propofol/tramadol. Control times were obtained prior to drug administration, then immediately before surgery, and at the end of surgery. Each patient was asked to move as many pegs as they could in 45 seconds from one side of the board to the other and back again (after familiarization with this technique).

Operating conditions were graded by the maxillo-fa-cial surgeon at the end of the procedure according to the movement during surgery as follows: continuous movement making treatment difficult, some movement but no interference with surgery, and no movement. At the end of the procedure, the surgeon rated the overall effectiveness of the sedation as follows: very poor sedation making surgery impossible, poor sedation but treatment partially completed or completed with difficulty, good sedation but limited difficulty in completing procedure, and very good sedation with procedures completed without any difficulties. Patients remained in the recovery room for 4 hours after surgery, where recovery was assessed according to the Aldrete’s postanesthetic recovery score.

After discharge, nausea and vomiting as reported by patients were recorded. Patients returned to the hospital the following day. Clinical acceptability of the medication was made by means of a 5-point Verbal Rating Scale (VRS: 1 = excellent, 2 = good, 3 = moderate, 4 = poor, 5 = very poor).
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Statistical Analysis
All tests of the significance of differences were 2-tailed and a probability of .05 or less was accepted as significant. Various tests such as the Chi-square tests, Fisher Exact tests, and the Mann-Whitney tests were applied. Repeated measures using general linear models assessed the pain differences over time in the 2 groups. All statistical modeling and significance testing was performed using the SAS statistical package (CMS version 5.18).

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