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The “Off label” uses of neostigmine
- Dr Manjit George, Dr Meena Vijayaraghavan, Dr Sheela P, Dr Maya G (19 December 2005)
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Caudal neostigmine; a useful adjunct
- Rajesh Mahajan, Batra YK, Sushil kumar (26 November 2005)
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Caudal additives in children: Caution still advisable.
- Sumit Kumar Jha, Dr Swati Daftary. Consultant Anaesthetist. Paediatric Surgery Theatre. LTMG Hospital, Mumbai. India. (14 November 2005)
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Neostigmine as adjunct to caudal block
- Nicole Almenrader, Maurizio Passariello (3 October 2005)
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Dr Manjit George, Clinical Observer, Anaesthetics, Wythenshawe Hospital, Manchester, UK South Manchester University Hospitals NHS Trust, Dr Meena Vijayaraghavan, Dr Sheela P, Dr Maya G
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Dr Manjit George Clinical Observer Dept. of Anaesthetics Wythenshawe Hospital, Manchester, UK drmg1976@yahoo.co.in Dr Meena Vijayaraghavan, Consultant Anaesthetist, Medical College Trivandrum, India Dr Maya G Dr Sheela P It is with great interest that we read the editorial article on adjuncts to caudal block in children.(1) The practice of adding adjuncts to the local anaesthetic to prolong the duration of analgesia has been in vogue for quite some time now. The studies showing enhanced post operative analgesia with addition of neostigmine have to be considered once again in the light of the present discussion.(2,3,4) One of the issues raised by the author was the unacceptably high incidence of postoperative nausea and vomiting, with addition of neostigmine. A similar or higher incidence has been reported with caudal bupivacaine alone. As the use of prophylactic antiemetics has been advocated in paediatric population in the perioperative setting, we could argue that there is no harm in giving antiemetics preoperatively where caudal block is instituted.(5,6) Three studies have shown that addition of neostigmine to caudal bupivacaine gives extended duration of analgesia without increasing adverse effects.(2,3,4) We conducted a clinical study at the Paediatric Surgery Division of Medical College, Trivandrum, India, wherein, 40 children aged 2 – 6 years, ASA 1, posted for elective inguinal herniotomy were included. We compared caudal 0.25% bupivacaine 1ml/kg(Group B) and a combination of caudal 0.25% bupivacaine and 2mcg/kg of neostigmine(Group BN) made to 1ml/kg. After standard induction of anaesthesia, these children were positioned on their side and caudal block was given.Heart rate, respiratory rate, blood pressure and oxygen saturation were recorded before induction, after induction, intraoperatively every 5 min after the caudal block and postoperatively. These children were given i.v. ondansetron 0.1mg/kg towards the end of surgery.(7) Patient was evaluated in the post operative period using the AIIMS pain discomfort scale at 1, 2, 4,8,12 and 24 hours after the caudal block. Rescue analgesia, in the form of syrup paracetamol 15mg/kg was given, when pain scores were more than or equal to 4 at any time during the 1st 24 hours. Quality of sleep, incidence of nausea and vomiting, time to 1st movement of lower limbs and time to 1st micturition were looked for. The mean time to 1st analgesia was 6.52 hours in Group B while it was 15.16 hours in Group BN. Subjects in Group B required more analgesic doses than those in Group BN. Interestingly, incidence of postoperative vomiting in either of the groups was zero!! Having said that, it needs to be admitted that the test population studied was small. Although there was statistically significant postoperative sedation and delay in micturition in Group BN compared to Group B, these side effects weren’t serious ones taking into consideration the fact that there was significant prolongation of the analgesic effect. These observations were different from what was observed in other studies.(2,4) Our conclusions are 1)Addition of Neostigmine 2mcg/kg to 0.25% Bupivacaine for caudal anaesthesia prolongs the duration of postoperative analgesia and reduces the requirement for postoperative analgesics significantly 2)Administration of preoperative prophylactic antiemetics has been quite useful to negate the incidence of postoperative nausea and vomiting.(5,6) The concern about “off label” use of anaesthetic drugs is still under review, but the prescription of drugs for unapproved(off label) uses is entirely proper, since the decision regarding how to use a drug is based on what is considered “good medical practice”.(8) By obtaining peer reviewed information from high quality medical journals on the use of anaesthetic drugs and devices, anaesthesia providers will be able to practice evidence based medicine rather than limiting their practice to information provided in the manufacturer’s package insert.(9) References (1) Lonnqvist PA. Adjuncts to Caudal Block in children- quo vadis? BJA 2005; 95(4)431-3 (2) Abdulatif M et al. Caudal Neostigmine, Bupivacaine and their combination for post operative pain management after hypospadias surgery in children. Anaesth Analg 2002;95(5) 1215-8 (3) Almenrader et al. Caudal additives for post operative pain management in children: S(+) Ketamine and Neostigmine. Paeditr Anaesth 2005;15(2):143 -7 (4) P Kumar, A Rudra, A K Pan, A Acharya. Caudal Additives in Paediatrics- A comparison among Midazolam, Ketamine and Neostigmine co administered with Bupivacaine. Anaesth Analg 2005;101:69-73 (5) Leeser J et al. Prevention of post operative nausea and vomiting using Ondansetron. Anaesth Analg 1991; 72:751-5 (6) Ummenhofer W et al. Effect of Ondansetron in prevention of postoperative nausea and vomiting in children. Anesthesiology 1994;81:804-10 (7) Tang J, Wang B, White PF, et al. The effect of timing of ondansetron administration on its efficacy, cost effectiveness, and cost benefit as a prophylactic anti emetic in the ambulatory setting. Anaesth Analgesia 1998; 86:274- 82 (8) Blumer JL. Off label use of drugs in children. Paediatrics 1999; 104:598-602 (9) Paul F White. Need Information on off label uses of anaesthetic drugs? Just ask the pharmaceutical representative! Anaesth Analg 2002; 95:1474-5 Conflict of Interest:None declared |
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Rajesh Mahajan, doctor ASCOMS ,JAMMU, Batra YK, Sushil kumar
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We were interested in the recent editorial regarding adjuncts to caudal block in children by Lannqvist PA. 1 Although author has well summarized the adjuvant and drawn conclusions and recommendations to safeguard the practice of caudal analgesia, the decision to condemn the caudal neostigmine seems to be a hurried one. Author has opined that due to high incidence of post operative nausea and vomiting( PONV) (30%) with caudal neostigmine, no further studies are required and its use to be restricted only to reverse neuromuscular blockade. Author has concluded so on the basis of two studies 2, 3 .In the first study quoted by the author wherein Almenrader and colleagues co -administered caudal S(+)-ketamine 1.0 mg.kg-1 and neostigmine of 10µg.kg-1 for pediatric surgery, only marginal prolongation of post operative analgesia was seen with addition of caudal neostigmine to ketamine with an high incidence (30%) of PONV .2 However this is not surprising. In our early dose response study of caudal neostigmine, we have already demonstrated poor analgesic efficacy of caudal neostigmine given alone in doses of 10µg.kg-1 with 20% incidence of PONV with increase in this incidence with higher doses of caudal neostigmine 4. Further caudal ketamine in dose range of 0.5-1.0 mg.kg-1 is associated with 10-25% incidence of PONV 5-8. Besides synergistic action of caudal neostigmine with bupivacaine does not assure its synergistic analgesic effect with caudal ketamine. Rather it may have been possible that ketamine may have potentiated the emetic action of caudal neostigmine. Authors have referred to an another study by Abdulatif and colleagues in which caudal neostigmine in dose of 2µg.kg-1 with bupivacaine was found to be efficacious in pediatric patients, albeit with high incidence of PONV (30%). 3In our dose-response study, we have found dose independent analgesic effect of caudal neostigmine with 2µg.kg-1 being the optimal dose to be used with caudal bupivacaine.9 However we found a 15% incidence of PONV. Similarly Turan and colleagues and Kumar and colleagues have reported 13-15% incidence of PONV with caudal neostigmine with local anesthetics.8-10 All these three studies have concluded that administration of caudal neostigmine 2µg.kg-1 with local anesthetics, offers an advantage of extended duration of post operative analgesia without increasing the incidence of adverse effects. Further a similar or even a higher incidence of PONV has been reported with the use of caudal bupivacaine alone.5, 10, 11 In conclusion, Not withstanding this adverse effect of PONV ,the favorable hemodynamic and respiratory profiles of extradural neostigmine ,do make it an attractive alternative to currently used caudal antinociceptive drugs and its use in main stream practice for caudal may be well advocated along with its routine iv use for reversing neuromuscular blockade. REFERENCES 1. Lonnqvist PA. Adjuncts to caudal block in children- Quo Vadis? Br J Anaesth 2005; 95:431-3 2. Almenrader N, Passariello M, D”Amica G, Haiberger R, Pietropaoli P. Caudal additives for post-operative pain management in children : S(+) Ketamine and neostigmine Paediar Anaesth 2005;15:143-7 3. Abdulatif M, EL-Sanabary M. Caudal neostigmine ,bupivacaine and their combination for post-operative pain management after hypospadiasis surgery in children. Anesth Analg 2002 ;95:1215-18 4. Batra YK, Arya VK , Mahajan R, , Chari P Dose response study of caudal neostigmine for postoperative analgesia in pediatric patients undergoing genitourinary surgery. Paeditr Anaesth 2003; 13:515-21 5. Naguib M, Sharif AMY, Seraj M, Gammal M EL, Dawlatly AA. Ketamine for caudal analgesia in children: Comparison with caudal bupivacaine .Br J Anaesth 1991; 67:559-64 6. Panjabi N, Prakash S, Gupta P ,Gogia A, Efficacy of three doses of ketamine with bupivacaine for caudal analgesia in pediatric inguinal herniotomy. Reg Aesth Pain Med 2004; 29:28-31 7. Gunes Y, Secen M, Ozcengiz D , Gunduz M, Balcioglu O, Isik G. Comparison of caudal ropivacaine ,ropivacaine plus ketamine and ropivacaine plus tramadol administration for postoperative analgesia in children. Paeditr Anaesth 2004; 14:576-6 8. Kumar P, Rudra A, Pan AK, Acharya A. Caudal Additives in pediatrics: a comparison among midazolam, ketamine and neostigmine co administered with bupivacaine . Anesth Analg 2005; 101:69-73 9. Mahajan R, Grover VK, Chari P. Caudal neostigmine with bupivacaine produces a dose independent analgesic effect in children. Can J Anesth 2004; 51:702-6 10. Turan A, Memis D, Basaran UN ,Karamanlioglu B, Sut N. Caudal ropiovacaine and neostigmine in pediatric surgery. Anesthesiology 2003; 98:719-22 11. William M, Splinter WM, Reid CW, et al .Reducing pain after inguinal repair in children: caudal anesthesia versus ketorolac tromethamine. Anesthesiology 1997; 87:542-6 12. Hannallah RS, Broadman LM, Belman B, Abromowitz MD , Epstein BS. Comparison of caudal and illioinguinal/ illiohypogastric nerve blocks for the control of post-orchiopexy pain in pediatric ambulatory surgery. Anesthesiology 1987; 66:832-4 Conflict of Interest:None declared |
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Sumit Kumar Jha, Senior House Officer Addenbrooke's Hospital NHS Trust, Cambridge., Dr Swati Daftary. Consultant Anaesthetist. Paediatric Surgery Theatre. LTMG Hospital, Mumbai. India.
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I read with interest the Editorial article of Dr P A Lonnqvist on adjuncts to caudal block in children. The well-written article describes the current strategies in caudal blocks in children. I would also agree with him that any therapeutic interventions in this patient subpopulation should involve a thorough and focussed approach and taking into consideration any long-term sequels. I would like to share my experiences and conclusions in a similar study we conducted last year. We studied 50 ASA I/II children at Paediatric Surgery Theatre suite, LTMG Hospital, Mumbai. India. We have used 0.25% Bupivacaine caudally and additives in the form of either 0.5mg/kg preservative-free ketamine or 5micrograms/mL adrenaline for postoperative pain relief in children undergoing infraumbilical surgeries. Methods: We studied children, aged up to 8 yr, undergoing infraumbilical surgeries. After standard induction and intraoperative pain control with fentanyl, Group K received 0.25% Bupivacaine with 0.5 mg/kg preservative –free ketamine and Group A received 0.25 % Bupivacaine with 5micrograms/mL adrenaline via the caudal route at the end of surgery. Heart rate, mean arterial pressure, and pulse oximetry were recorded before induction, after induction, intraoperatively and then postoperatively every 10 min after caudal anaesthesia. Haemodynamic, sedation score values were recorded 30 min after extubation and at hours 2, 4, 6, 12, and 24. The rescue analgesic used was rectal paracetamol. Results: There were no differences between the groups in demographic data, duration of surgery/anaesthesia and time to extubation. The pain scores were significantly lower in ketamine group at 6, 12 h and up to 18 hours (P < 0.05). Time to first analgesic requirement was statistically prolonged in this group (18.1 +/- 3.2h) when compared with adrenaline (11.2 +/- 2.6 h) (P < 0.05). The sedation scores were also higher in the ketamine group.
We concluded that: 1. Preservative-free Ketamine as additive to Bupivacaine significantly prolonged the duration of postoperative pain relief in children: as compared to adrenaline as additive. We found that it is an effective agent especially in the setting of single-shot caudal techniques. 2. Sedation scores were higher in the ketamine group and this necessitated that patients were cared for in an HDU environment at least for 24 years with pulse oximetry and apnoea monitoring. 3. Ketamine offered better pain relief in visceral surgeries and hypospadias. This we believed to be due to actions of ketamine on peripheral pain receptors at the spinal cord level. 4. On review of literature, ketamine has been demonstrated to have age-related neurotoxicities in rat models related to NMDA antagonism. This necessitated long-term follow-up of these patients and using preservative- free drugs. The latest literatures confirm our belief in the efficacy of Ketamine, as a caudal additive for pain relief in children but long-term follow-up of patients is crucial to know if there are any long-term side- effect profiles attributable to ketamine. The ethical issues involved especially in the context of paediatric Anaesthesia cannot be overemphasised. Having said that, the pain relief issues, especially postoperative pain relief, in the paediatric population remains a pertinent question and challenges the paediatric Anaesthetist. References 1. Jha S, Daftary S: Caudal additives for postoperative pain relief in children. A prospective, randomized study of 50 ASAI/II children undergoing infraumbilical surgeries. 2. Comparison of the effects of adrenaline, clonidine and ketamine on the duration of caudal analgesia produced by bupivacaine in children. British Journal of Anaesthesia, Vol 75, Issue 6 698-701 3. Comparison of the effect of ketamine added to bupivacaine and ropivacaine, on stress hormone levels and the duration of caudal analgesia Acta Anaesthesiologica Scandinavica: Volume 49 Issue 10 Page 1520 - November 2005 4. Age-specific neurotoxicity in the rat associated with NMDA receptor blockade: potential relevance to schizophrenia? Nuri B. Farber , David F. Wozniak, Madelon T. Price, Joann Labruyere, Janice Huss, Heidi St. Peter and John W. Olney. Biol Psychiatry. 1995 Dec 15; 38(12): 788-96. Conflict of Interest:None declared |
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Nicole Almenrader, Department of Anaesthesia and Intensive Care Policlinico Umberto I, Viale del Policlinico 155, 00161 Rome, Italy, Maurizio Passariello
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Sir – We read with great interest the editorial by PA Lönnqvist(1) regarding caudal additives. The author gives an excellent description of the chronological development of caudal adjuncts. Nevertheless, we were somewhat surprised by his affirmations regarding caudal neostigmine: the author claims that 2 studies are proof enough to show that caudal neostigmine has no role in the caudal space, but it’s use should only be limited to the reverse of neuromuscular block - “no further studies are needed”! First of all, only two(3,8) of the 7 studies on caudal neostigmine in children have been mentioned. Sample sizes of these 2 studies are quite small (N=30 and N=20), therefore it seems premature to draw any sound conclusions. Four studies(2,4,7,8) showed a significant prolongation of postoperative analgesia when neostigmine was added to local anaesthetic (5-8 hrs vs. 16 -22 hrs). A dose finding study clearly showed dose-dependent analgesia of caudal neostigmine(5). A study performed by our group showed a ketamine sparing effect of neostigmine with a postoperative analgesia of 21.8 hrs(3). Only one study(6) so far did not observe a significant advantage in terms of analgesia when adding neostigmine to bupivacaine. Secondly, a 30% incidence of PONV as observed in the two(3,8) mentioned studies is defined by the author as unacceptable. Again of the 7 studies on caudal neostigmine in children 4 studies(2,4,6,7) could not show a significant increase in PONV. A dose dependent increase of PONV has been described in the dose finding study(5), but only with doses of 30 mcg/kg or higher. The 30% incidence of PONV encountered in our study(3) might be due to the higher dose of neostigmine (10 mcg/kg) used, but nevertheless only mild PONV was observed as no child presented more than one single episode of vomiting. The same or even higher incidence of PONV can be observed with caudal opioids(9,10). The effectiveness of antiemetics on preventing neostigmine induced PONV still needs to be tested. With regard to safety, all studies so far show that caudal neostigmine has a reasonably benign profile with dose-dependent nausea and vomiting the only reported side-effect. In our study the preservative-free formulation has been used and this is strongly recommended. We agree with the author that prospective randomized trials of adequate size are warranted to answer important questions regarding new caudal adjuncts and prevent to make caudal block fall into disrepute. It might be true, that caudal neostigmine will not become an alternative to clonidine or ketamine, but only a large number of studies with adequate power will enable us to decide whether caudal neostigmine should be adopted into mainstream clinical practice or not. References: 1. Lönnqvist PA. Adjuncts to caudal block in children-quo vadis? BJA 2005; 95(4): 431-3. 2. Kumar P et al. Caudal additives in pediatrics: a comparison among midazolam, ketamine and neostigmine coadministered with bupivacaine. Anesth Analg 2005; 101(1): 69-73. 3. Almenrader N. et al. Caudal additives for postoperative pain management in children: S (+)- ketamine and neostigmine. Paediatr Anaesth 2005; 15(2): 143-7. 4. Mahajan R. et al. Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children. Can J Anaesth 2004; 51(7): 702-6. 5. Batra YK. et al. Dose response study of caudal neostigmine for postoperative analgesia in paediatric patients undergoing genitourinary surgery. Paediatr Anaesth 2003; 13(6): 515-21. 6. Memis D. et al. Caudal neostigmine for postoperative analgesia in paediatric surgery. Paediatr Anaesth 2003; 13 (4): 324-8. 7. Turan A. et al. Caudal ropivacaine and neostigmine in pediatric surgery. Anesthesiology 2003; 98(3): 719-22. 8. Abdulatif M. et al. Caudal neostigmine, bupivacaine and their combination for postoperative pain management after hypospadias surgery in children. Anesth Analg 2002; 95(5): 1215-8. 9. Moriarty A. Postoperative extradural infusions in children: preliminary data from a comparison of bupivacaine/diamorphine with plain ropivacaine. Paediatr Anaesth 1999; 9: 423-427. 10. Goodarzi M. Comparison of epidural morphine, hydromorphone and fentanyl for postoperative pain control in children undergoing orthopaedic surgery. Paediatr Anaesth 1999; 9: 419-422. Conflict of Interest:None declared |
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