Mean VAS for pain ranged from 26.0 (group A) to 29.9 (group D), with no significant differences between groups ( ANOVA, 2-tailed t -tests). Pain data for the initial postoperative assessment are shown in Table 2. There were also no significant differences in the number of patients requesting postoperative analgesia, ranging from 18/25 (72%; group B) to 23/28 (82; group A). In all groups, the vast majority of patients requesting postoperative analgesia found it to be effective.
Its lack of sedative and respiratory depressant effects might be expected to make tramadol a suitable analgesic for use in day-case oral surgery. Furthermore, NSAIDs are associated with numerous side-effects, and are contraindicated in a significant number of patients; tramadol might be expected to have a place as an alternative for such patients, although this possibility was not examined in our study. Nonetheless, because tramadol acts by quite different mechanisms to NSAIDs, we felt that the combination might provide analgesia superior to that of either drug alone; thus all our patients were given diclofenac orally pre-operatively. However, third molar tooth extractions are associated with considerable postoperative inflammation, and it could be argued that NSAIDs are more appropriate for such surgery than tramadol, which lacks anti-inflammatory action.
The study was approved by the local ethics committee. Patients in whom there was: inability or unwillingness to give written consent, contraindications to the use of NSAIDs, Parkinsonism or history of extrapyramidal reaction to metoclopramide or other drugs, use of other analgesics in the 12 h prior to surgery, contraindications to tramadol, hypersensitivity, monoamine oxidase inhibitor therapy, severe renal or hepatic disease, or epilepsy were not studied. Patients were included who were aged between 18 and 60 years of age, ASA I or II, and who gave informed written consent. We chose to perform a randomised, double-blinded comparative study with four groups, each of 30 patients, all of whom were scheduled to undergo elective multiple third molar tooth extractions as day cases.
Occurrence and frequency of vomiting were noted, as was the need for analgesics and anti-emetics up until that time, and the effect of these. Standard 100-mm visual analogue scales (VAS) were used to assess pain and nausea. To ensure blinding, these were performed by an assessor who had not anaesthetised the patient and who was unaware which study drugs had been given intra-operatively. The occurrence of any side-effects or other problems was recorded, whether or not these were thought to be related to the treatment. At 2 h postoperatively, patient assessments were carried out.
View issue TOC Volume 54, Issue 3 March 1999 Pages 289–292.
A written questionnaire was given to all patients to complete at 24-h postoperatively. The following information was sought: degree of pain experienced since leaving hospital, rated as none, mild, moderate or severe; degree of nausea, rated in the same way; occurrence and frequency of vomiting; need for analgesics during this period and their effectiveness; occurrence of any other problems. In addition, patients were ephoned at around this time to obtain answers to the written questions and to encourage return of the questionnaire. In addition, if any patient needed to be admitted as an inpatient, this was recorded, along with the reason.
Similarly, there was no significant difference in the number of patients in each group who self-administered oral analgesics (dextropropoxyphene–paracetamol and/or ibuprofen) during this time (figures ranging from 87% for group C to 96% for group A), or in the total number of occasions on which such analgesia was taken. Tables 4 and 5 show data obtained from the post-discharge questionnaire, covering the first 24 h following discharge. There was no significant difference in the number of patients who rated their pain as moderate to severe during this period, figures varying from 39% (group C) to 54% (all other groups). The vast majority of patients found this analgesia to be at least partly effective.
This prospective, randomised double-blinded study was designed to assess the analgesic efficacy and occurrence of nausea when tramadol is added to a nonsteroidal anti-inflammatory drug to provide analgesia following day-case third molar teeth extraction. All patients received oral diclofenac pre-operatively and one of four treatments intra-operatively: fentanyl and metoclopramide, tramadol and metoclopramide, fentanyl and ondansetron, or tramadol and ondansetron. However, there were significant differences in nausea scores at this time, with the fentanyl–ondansetron group having the lowest and the tramadol–ondansetron group having the highest scores. There were no significant differences between groups in scores for pain in the early postoperative period. We conclude that the addition of tramadol to diclofenac results in no useful improvement in analgesic effect, and that the use of ondansetron fails to reduce the nausea associated with tramadol. There were no significant differences in the incidence of pain or nausea in the following 24 h.
However, we have shown that the addition of tramadol to a NSAID results in no useful improvement in analgesic efficacy, and that the use of ondansetron does not result in any reduction in the nausea associated with tramadol. Because all our patients received a NSAID, our results cannot give clear information as to whether tramadol has a place as an alternative to NSAIDs in oral surgery when the latter are contraindicated.
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All patients received 75 mg of diclofenac orally, 1 h pre-operatively. All study drugs were administered intravenously following the induction of anaesthesia. Patients were randomly allocated into four treatment groups: group A received metoclopramide 10 mg and fentanyl 100 μg; group B, metoclopramide 10 mg and tramadol 100 mg; group C, ondansetron 4 mg and fentanyl 100 μg; and group D, ondansetron 4 mg and tramadol 100 mg. Local anaesthetic techniques were not employed. A standardised anaesthetic technique was employed. Anaesthesia was maintained with a propofol intravenous infusion at 6 mg.kg−1.h−1 and inhaled nitrous oxide and enflurane in oxygen, the enflurane concentration being adjusted as clinically indicated. Induction was with propofol and muscle relaxation with vecuronium, in appropriate doses. No sedative premedication was given.
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Its lack of sedation is of particular value to day surgery patients. Its main advantages over conventional opioids are a relative lack of sedative action and respiratory depression, and a reduced potential to cause dependence. Tramadol is a centrally acting analgesic of moderate potency with both opioid and nonopioid modes of action.
In all, 109 patients were recruited; 83 were female. Eleven patients were withdrawn from the study, six because of the need for more extensive surgery and five due to failure to return post-discharge questionnaires. There were no significant differences between the four groups with regard to age, sex or weight ( Table 1 ).
It might be worthwhile to study the use of oral tramadol during the 24–48 h after surgery, compared with standard drugs such as NSAIDs and/or oral opioid–paracetamol combinations. The aim of this study was to assess the early postoperative effects of tramadol given intra-operatively, and it is not surprising that there were few differences in pain and nausea parameters between the groups during the 24 h following discharge.
Kruskal–Wallis one-way ANOVA was used to ascertain whether there was an overall difference between groups. Despite these results for nausea and vomiting, only three patients in total requested anti-emetics, two of whom obtained satisfactory relief. This was significantly higher than for group C (fentanyl–ondansetron), the lowest scoring group (p < 0.001; Mann–Whitney U -test), but not group A or B. This revealed that there was a highly significant difference between groups ( p < 0.01; Table 3 ). On comparing individual groups, the highest score was 19.85 for group D (ondansetron–tramadol). Analysis of our results for early postoperative nausea VAS revealed these not to be normally distributed, with a preponderance of lower scores resulting in a positive skewness. Nonparametric tests were thus used for significance testing of these data. The score of 1.5 for group C was significantly lower than for group A (p < 0.05) and group B (p = 0.05), as well as group D (p < 0.001). However, the third patient (in group D) had to be admitted to a ward overnight due to persistent, severe PONV. Although there was a trend to a higher incidence of vomiting in group D (five patients vomiting on a total of 11 occasions), this did not reach significance.
Such procedures are associated with significant inflammation, hence nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to provide postoperative analgesia. Because tramadol acts by different mechanisms, its use in combination with a NSAID might be expected to produce better pain relief than either drug alone. Third molar teeth extractions are often performed on a day-case basis.
PONV poses particular problems in day surgery, being a major cause of overnight admission to hospital, and for this reason we decided to give all our patients anti-emetics. Furthermore, we used propofol to maintain anaesthesia in order to reduce the need for enflurane with its associated emetic effect. Nonetheless, there were clear differences between groups. Although oral surgery is itself associated with a comparatively low incidence of PONV, tramadol appears to be at least as emetogenic as morphine. However, the highest nausea VAS score was for the tramadol–ondansetron group, and there was also a higher incidence of vomiting at this time in these patients, although this did not reach significance. The fentanyl–ondansetron group had a significantly lower score than any of the other three groups, a finding which is not surprising in view of previous work demonstrating the efficacy of ondansetron as a peri-operative anti-emetic. Perhaps because of these measures, the actual nausea VAS scores in the early postoperative period were comparatively low.
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G. J. Wardall Department of Anaesthetics, Falkirk and District Royal Infirmary, Major's Loan, Falkirk FK1 5QE, UK.
We are grateful to Sister S. Lawlor and the staff of the Day Surgery Unit, Falkirk Royal Infirmary, for their help throughout this study. Blackwell Science Ltd Request Permissions.
Its efficacy appears to be enhanced by synergistic actions of its (+) and (−) enantiomers. This apparent lack of analgesic efficacy is surprising as it has been found previously that tramadol 100 mg has a potency comparable with that of morphine 10 mg. Tramadol exerts its analgesic effect both through opioid actions, being a weak μ-agonist, and by reducing the reuptake of monoamines (5-HT and noradrenaline) in descending inhibitory pathways in the spinal cord. However, our findings suggest that these actions contribute little to analgesia following oral surgery, at least when tramadol is combined with the pre-operative administration of a NSAID. It is disappointing, therefore, that the two tramadol groups should have virtually identical pain scores to those given fentanyl, the effect of which would be expected to largely have worn off early in the postoperative period.
Our objective, therefore, was to study the use of tramadol for analgesia following day-case oral surgery (third molar teeth extractions) in combination with a NSAID, and to assess the anti-emetic efficacy of ondansetron compared with a conventional anti-emetic. However, the use of tramadol in day surgery is potentially limited by its high incidence of postoperative nausea and vomiting (PONV). Thus a 5-HT 3 antagonist such as ondansetron might be of particular value in reducing the PONV associated with tramadol. It has been suggested that because part of the analgesic effect of tramadol is mediated by a reduced uptake of 5-hydroxytryptamine (serotonin, 5-HT) in descending pathways in the spinal cord, raised 5-HT levels might contribute to its emetic effect.
Vickers has suggested that 5-HT 3 antagonists might be of particular value in reducing the PONV associated with tramadol, since one action of the latter is to block 5-HT reuptake. Furthermore, the only patient admitted overnight with severe PONV was from this group. It is surprising, therefore, that in this study the tramadol–ondansetron group should have the worst early nausea scores. In addition, the 5-HT receptors involved in PONV are found at sites in the periphery and CNS which are different to those at which tramadol exerts its analgesic effect, and it may be that tramadol has less effect on 5-HT reuptake at the former sites. It has been suggested that noradrenaline (and adrenaline) acting on alpha-1 and alpha-2 receptors in the area postrema are implicated in emesis. The explanation for this is unclear, but tramadol might also cause nausea through its opioid effects and via its action to increase noradrenaline levels through reduced uptake.
The study was designed to have a power of 80% to detect a 30% difference in pain or nausea score between any two groups at a probability level of 0.05. Data were analysed by parametric ( ANOVA, unpaired t -tests) and non parametric (Chi-squared, Mann–Whitney U and Kruskal–Wallis one-way ANOVA ) tests as appropriate, and a significance level of p < 0.05 was used.
Postoperatively, patients received standardised analgesic therapy (two tables of dextropropoxyphene 32.5 mg, paracetamol 325 mg (‘coproxamol’) and ibuprofen 400 mg, up to 6-hourly) and anti-emetic therapy (intramuscular prochloperazine 12.5 mg up to 8-hourly). Concomitant treatment with other analgesics was not allowed.
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