Ondansetron for the prevention and treatment of nausea and vomiting following pediatric strabismus surgery

BACKGROUND: Neither droperidol nor ondansetron has been proven completely effective, and there are conflicting data comparing the efficacy of the two agents. The purpose of this study was to compare the efficacy, safety and cost of a combination of ondansetron administered intravenously in the operating room followed by oral ondansetron treatment at home with the more commonly used treatment of intravenous droperidol therapy and oral dimenhydrinate therapy, for the prevention and treatment of postoperative nausea and vomiting in children undergoing strabismus surgery. METHODS: Double-blind randomized clinical trial with parallel comparison groups. All patients aged 6 months to 18 years who underwent strabismus surgery at a pediatric hospital in Montreal between Nov. 13, 2000, and June 12, 2001, were included. The exclusion criteria were nausea or vomiting, or use of antiemetics or narcotics in the 24 hours preceding surgery, and past history of hepatic, gastric or renal disease. The outcome measures were frequency of nausea and vomiting, severity of nausea and adverse effects in hospital, during transportation home and during the first 24 hours at home. Data were obtained through nursing notes and through a telephone interview conducted 24 to 48 hours after discharge. RESULTS: Of the 208 eligible patients, 172 were randomly assigned to the study groups (88 to the ondansetron group and 84 to the droperidol/dimenhydrinate group). We found no statistically significant difference in the incidence of nausea and vomiting in hospital or at home between the two groups (25.3% vs. 31.6%, p = 0.371). There was a significant difference between the two groups in the rate of vomiting during transportation home (3.6% vs. 12.6%, p = 0.044). The incidence of severe nausea was 14.4% with ondansetron and 15.4% with droperidol, a nonsignificant difference (p = 1.00). No significant difference was observed between the two groups in the incidence of any nausea (p = 0.434) or adverse effects (p = 0.220). We calculated that the combination of droperidol and dimenhydrinate was seven times less costly than the ondansetron regimen. INTERPRETATION: In this study, the efficacy and safety of intravenous administration of droperidol followed by oral use of dimenhydrinate did not differ from that of intravenous followed by oral use of ondansetron in children undergoing strabismus surgery. Since treatment with ondansetron is much more costly than the combination of droperidol and dimenhydrinate, at this time the use of ondansetron in the prevention and treatment of vomiting and nausea in this population may not be beneficial on a cost basis if all other variables are considered.     

阿扎司琼预防眼外伤手术后恶心呕吐的观察

目的观察比较阿扎司琼(azasetron)预防眼外伤手术后恶心呕吐的效果。方法眼外伤手术75例,随机分为对照组(A组)、氟哌利多(droperidol)组(B组)和阿扎司琼组(C组),每组25例。在手术结束前,A、B、C组分别静脉注射生理盐水5mL、氟哌利多5mg或阿扎司琼10mg,观察每位患者用药后恶心呕吐发生情况。结果眼外伤手术后恶心呕吐的发生大多数在术后24h内,呕吐发生率,C组小于B组(P<0.05),B组小于A组(P<0.05)。结论本研究表明阿扎司琼是一种安全有效的预防眼外伤手术后恶心呕吐的药物。     

Subtenons lidocaine injection for postoperative pain relief after strabismus surgery in children: A prospective randomized controlled trial.

BACKGROUND: We previously reported a pilot study of the use of subtenons lidocaine after primary, unilateral strabismus surgery in children. This study suggested an association between subtenons lidocaine administration at the conclusion of surgery and a reduction of pain in the immediate postoperative period. As a result of this pilot study we performed a full-scale prospective, randomized controlled trial to fully evaluate the efficacy of this intervention. METHODS: Children undergoing primary surgery or reoperations for strabismus were recruited. If randomized to the treatment group, 1 ml of 2% lidocaine was injected into the subtenons space of each operated eye, just prior to conjunctival closure. The child's parents, who were masked to the intervention, assessed pain over 4 h postoperatively using an objective pain-scoring tool. Pain scores were recorded on return to the ward (0 h, approximately 20 to 30 min after the completion of surgery) and at 1, 2, and 4 h later. RESULTS: One hundred eleven children were recruited, of whom 91 (82.0%) underwent unilateral and 20 (18.0%) underwent bilateral surgery. Ninety operations (81.1%) were primary procedures and 21 (18.9%) were reoperations. Fifty-four children (48.6%) were randomized to the treatment group and 57 (51.4%) were randomized to the control group. A subtenons lidocaine injection was associated with a significant reduction in pain at the 0 h observation (P = 0.0056), and the total pain score over the 4-h postoperative period was significantly lower in the treatment group compared to controls (P = 0.0381). There was no difference between the groups with respect to the need for additional systemic analgesia (P = 0.307). CONCLUSION: This study showed that an intraoperative injection of subtenons lidocaine is associated with a significant reduction in postoperative pain during the first postoperative hour for all types of childhood strabismus surgery. There was no difference between the groups in the need for systemic analgesia.     

术前应用氟比洛芬酯与阿扎司琼对小儿斜视矫正术术后疼痛及呕吐的影响

目的 观察术前联合应用氟比洛芬酯与阿扎司琼对小儿斜视矫正术术后疼痛及恶心呕吐的影响.方法 临床病例对照研究.选择中山大学中山眼科中心就诊的60例按美国麻醉医师协会(ASA)标准的Ⅰ～Ⅱ级、年龄8～14岁、择期行斜视矫正术的患儿,均采用异丙酚、芬太尼及阿曲库胺全凭静脉麻醉,根据诱导前辅助用药的不同随机分为3组(n=20):FA组静脉推注氟比洛芬酯1mg/kg+阿扎司琼0.2mg/kg;F组给予氟比洛芬酯1mg/kg+等量生理盐水;A组给予阿扎司琼0.2mg/kg+等量生理盐水,均在诱导前10min静脉注射.观察术前、术始、术毕、术后各时点的镇痛评分(VAS)及血糖变化,并观察各组苏醒期躁动、术后咽喉部疼痛及恶心、呕吐等不良反应发生情况.结果 FA组和F组术后V.AS评分显著低于A组(P<0.05),术后各时点A组血糖水平明显高于FA组和F组(P<0.05),FA组和A组术后恶心呕吐发生率明显低于F组(P<0.05).结论 术前氟比洛芬酯与阿扎司琼联合应用于小儿斜视矫正术既可明显改善术后疼痛又能减少恶心呕吐等不良反应.

Abstract：

Objective To study the effect of preoperative flurbiprofen axetil combined with azasetron on postoperative pain and nausea and vomiting in children undergoing strabismus surgery. Methods A total of 60 children, ASA Ⅰ -Ⅱ, aged 8-14, scheduled for strabismus surgery with total intravenous general anesthesia were randomly assigned to 3 groups(n=20). In group FA, flurbiprofen axetil(1mg/kg)combined with azasetron(0.2mg/kg)was intravenously injected; only flurbiprofen axetil(1mg/kg)was give in group F and only azasetron(0.2mg/kg)was injected in group A. The above drugs were all administered 10 min before the anesthetic induction. VAS scores and glucose at the end of surgery and after surgery were recorded individually.The incidence rate of restless, nausea and vomiting after surgery were recorded. Results The incidence rate of pain in group FA and group F were significantly lower than that in group A(P <0.05). The postoperative glucose in group A were significantly higher than that in group FA and group F(P <0.05). The incidence rate of nausea and vomiting in group FA and group A were significantly lower compared with group F(P <0.05).Conclusions Flurbiprofen axetil combined with Azasetron can reduce the adverse reactions, such as pain,nausea and vomiting in children undergoing strabismus surgery.     

术前应用氟比洛芬酯与阿扎司琼对小儿斜视矫正术术后疼痛及呕吐的影响

Objective To study the effect of preoperative flurbiprofen axetil combined with azasetron on postoperative pain and nausea and vomiting in children undergoing strabismus surgery. Methods A total of 60 children, ASA Ⅰ -Ⅱ, aged 8-14, scheduled for strabismus surgery with total intravenous general anesthesia were randomly assigned to 3 groups(n=20). In group FA, flurbiprofen axetil(1mg/kg)combined with azasetron(0.2mg/kg)was intravenously injected; only flurbiprofen axetil(1mg/kg)was give in group F and only azasetron(0.2mg/kg)was injected in group A. The above drugs were all administered 10 min before the anesthetic induction. VAS scores and glucose at the end of surgery and after surgery were recorded individually.The incidence rate of restless, nausea and vomiting after surgery were recorded. Results The incidence rate of pain in group FA and group F were significantly lower than that in group A(P <0.05). The postoperative glucose in group A were significantly higher than that in group FA and group F(P <0.05). The incidence rate of nausea and vomiting in group FA and group A were significantly lower compared with group F(P <0.05).Conclusions Flurbiprofen axetil combined with Azasetron can reduce the adverse reactions, such as pain,nausea and vomiting in children undergoing strabismus surgery.     

Nonvitrectomizing vitreous surgery: a strategy to prevent postoperative nuclear sclerosis.

OBJECTIVE: The development or progression of postoperative nuclear sclerosis is the most common complication of successful vitrectomy in elderly patients. The authors treated idiopathic epimacular proliferation (EMP) with nonvitrectomizing vitreous surgery in an attempt to prevent postoperative nuclear sclerosis. DESIGN: Prospective, nonrandomized, comparative case series. PARTICIPANTS: The authors surgically removed membranes from the sensory retina in 21 eyes of 21 patients with EMP. INTERVENTION: Neither intravitreal infusion nor vitrectomy of any kind was performed during the procedure. The peeled membrane was left floating in the vitreous cavity in 11 (group 1) eyes and removed in 10 eyes (group 2). Nonoperated fellow eyes served as controls. MAIN OUTCOME MEASURES: Visual acuity, slit-lamp and/or Scheimpflug photography, and refractometry were performed pre- and postoperatively to evaluate changes in the degree of lenticular opacity. RESULTS: There was no difference in the rate of development or progression of nuclear sclerosis or the degree of myopic shift between operated and control eyes during the postoperative follow-up period (mean, 9.7 months). No serious complications were noted. There was no difference in postoperative course between patients in the two operative groups. CONCLUSIONS: Although interpretation of the results of this study is limited due to its small size and short follow-up, nonvitrectomizing vitreous surgery seems to decrease the postoperative development or progression of nuclear sclerosis in patients with idiopathic EMP.     

不同时间给予昂丹司琼预防小儿斜视术后恶心呕吐的临床观察

目的：不同时间静脉注射昂丹司琼在小儿斜视术后恶心呕吐（postoperative nausea and vomiting,PONV）中的效果观察。方法：随机选择2013-06/08在我院拟行斜视手术的患儿90例,ASAⅠ～Ⅱ级,年龄3～11岁。随机分为3组,每组30例。A组在手术开始前静脉注射昂丹司琼0.1mg/kg; B组在手术结束后静脉注射昂丹司琼0.1mg/kg; C组为对照组,不用昂丹司琼。在术后24h内观察患者恶心、呕吐的发生例数及严重程度。结果：三组患者的性别、体重、年龄、麻醉时间、氯胺酮用量各组间比较无统计学意义（P〉0.05）。A,B组的PONV发生率明显低于C组（P〈0.05）,A组和B组的PONV发生率比较无统计学意义（P〉0.05）。结论：在手术前或手术结束时应用昂丹司琼可有效、安全地预防小儿斜视手术后的PONV,提高眼科手术安全性,且费用低,是一种值得推广应用的止吐方法。     

Adjunctive intra-operative local anaesthesia in paediatric strabismus surgery: A randomized controlled trial

Purpose: The aim of the present study was to test the hypothesis that adjunctive local anaesthesia decreases postoperative pain, vomiting or length of stay in children having strabismus repair Method: A prospective, randomized, triple-armed clinical trial involving a treatment comparison between topical amethocaine, sub-conjunctival bupivacaine and, as a placebo, topical normal saline was performed. All treatments were given at the end of surgery before emergence from the anaesthetic. Results: Overall, there was no statistically significant difference between outcome measures in the three trial groups. Using post hoc analysis there was a statistically significant difference between the groups receiving amethocaine and bupivacaine compared with the saline group in terms of the pain score at 120 min postoperatively. This difference has little clinical significance. Conclusions: Neither topical amethocaine nor subconjunctival bupivacaine makes a clinically significant difference to postoperative pain, emesis or length of stay. Moderate dose paracetamol per rectum alone appears to be effective analgesia for strabismus surgery, although it probably masked any small adjunctive effect of the topical anaesthesia used in the present trial.     

Subtenons lidocaine injection for postoperative pain relief after strabismus surgery in children: a pilot study.

BACKGROUND: Ophthalmologists are now encouraged to perform strabismus surgery as an outpatient procedure, but postoperative pain may be a barrier to discharge. Systemic analgesics have side effects or are contraindicated in some patients. We designed a trial to determine the efficacy of subtenons lidocaine injection at reducing postoperative pain and systemic analgesia requirements. METHODS: Children having unilateral primary horizontal muscle surgery were randomized to either receive an injection of 1 mL of 2% lidocaine into the inferonasal subtenons space or not. The child's parents, who were masked to the intervention, assessed pain over 4 hours postoperatively using an objective pain-scoring tool. RESULTS: Seventeen children received injections and 14 did not. Five of the subtenons group required additional analgesia (29%) compared to 9 of the controls (64%, chi(2): P =.052). The pain scores at each time interval tended to be lower in the treatment group, compared to controls, statistically significantly so at the 2-hour observation (Mann-Whitney U test: P =.01). CONCLUSIONS: These data provide some evidence of an association between the use of subtenons lidocaine injection and a reduction of pain experienced by children in the immediate postoperative period following primary strabismus surgery.     

Intraoperative sponge 5-fluorouracil to reduce postoperative scarring in strabismus surgery.

INTRODUCTION: To determine whether 5-fluorouracil is effective in reducing scarring after strabismus surgery we used rectus muscle surgery in experimental animals to compare a single intraoperative dose of 5-fluorouracil with mitomycin C and to compare results in similarly treated controls not receiving these antimetabolites. METHODS: Muscle resections were performed on eight rabbits (16 eyes). Four eyes had 5-fluorouracil (50 mg/ml), and four eyes received mitomycin C (0.2 mg/ml), each of which was applied during surgery on an ophthalmic sponge for 5 minutes. Eight eyes served as controls. Six weeks after surgery conjunctival vascularity, muscle length-tension curves, muscle disinsertion force, and the histologic degree of scarring were assessed. RESULTS: The mitomycin C-treated eyes clearly had more conjunctival avascularity and a lower disinsertion force. Both treated groups had flatter length-tension curves and less scarring on histologic examination than the control eyes. CONCLUSIONS: Antifibroproliferative therapy with intraoperative sponge 5-fluorouracil appears as effective as, and is possibly safer than, mitomycin C. It may be a useful adjunct in recurrent strabismus surgery or in other situations where a risk of excessive postoperative scarring exists.     

Treatment of vomiting after paediatric strabismus surgery with granisetron,droperidol, and metoclopramide

We have compared the efficacy and safety of granisetron, droperidol, and metoclopramide in the treatment of postoperative vomiting (POV) in children scheduled for strabismus surgery. After experiencing POV during the first 3 h after recovery from anaesthesia, 120 patients received intravenously, in a randomized, double-blind manner, granisetron 40 microg/kg, droperidol 50 microg/kg, or metoclopramide 0.25 mg/kg (n = 40 in each group). The patients were then observed for 24 h after administering the study drugs. Emesis-free episodes were more often observed in patients who had received granisetron (88%) than in those who had received droperidol (63%) or metoclopramide (58%; p < 0.05). No clinically serious adverse events were observed in any group. In conclusion, granisetron is more effective than droperidol or metoclopramide in the treatment of POV after paediatric strabismus surgery.     

斜视手术前后双眼视觉的临床研究

目的探讨斜视对双眼视觉的影响及不同双眼视检查方法的评价。方法89例共同性斜视分为间歇性外斜、恒定性外斜及恒定性内斜3组。定量测量斜视度；检查双眼视觉状态及视网膜对应情况；测定远近立体视锐度。并观察斜视手术前及手术后1周、1月的斜视度、双眼视觉状态及远、近立体视锐度变化。结果3组术后双眼视功能较术前均有明显改善（P〈0．05），术后1周与1月双眼视功能的差异无统计学意义（P〉0．05）；恒定性斜视术后立体视恢复好于间歇性外斜视，且近立体视恢复好于表视；立体视检查非随机点画片（Titmus与Optec3500）与随机点画片（TNO）检查结果的差异有统计学意义（P〈0．05）；线状镜较Worth四点检测阳性率高；大于9岁患者术后双眼视觉较术前增加32％。结论斜视手术是恢复、重建双眼视觉的有效方法，不同检测方法结果不一致，需综合考虑。     

Final report of the early vs. late infantile strabismus surgery study (ELISSS), a controlled, prospective, multicenter study

BACKGROUND: The optimal age for surgery for infantile esotropia is controversial. Proponents of early surgery believe that further loss of binocular vision can be prevented by early surgery, a minority believes that binocular vision can even be restored by early surgery. The ELISSS compared early with late surgery in a prospective, controlled, non-randomized, multicenter trial. METHODS: Fifty-eight clinics recruited children aged 6-18 months for the study. Each clinic operated all eligible children either 'early', i.e. at age 6-24 months, or 'late', i.e. at age 32-60 months. At baseline the angle of strabismus, refraction, degree of amblyopia and limitation of abduction were assessed. Intermediate examinations took place every six months. Children were evaluated at age six in the presence of independent observers. Primary endpoints were (i) level of binocular vision, (ii) manifest angle of strabismus at distance and (iii) remaining amblyopia. Secondary endpoints were number of operations, vertical strabismus, angle at near and the influence of surgical technique. RESULTS: A total of 231 children were recruited for early and 301 for late surgery. Age at entry examination was 11.1 months (SD 3.7 months) in the early group and 10.9 (SD 3.7) months in the late group. Refraction, amblyopia and limitation of abduction were distributed equally in the early and late groups, but the angle of strabismus was slightly larger in the early group. Dropout-rates were 26.0% in the early and 22.3% in the late group. At age six, 13.5% of the early vs. 3.9% of the late group recognized the Titmus Housefly; 3.0% of the early and 3.9% of the late group had stereopsis beyond Titmus Housefly. No significant difference was found for angle of strabismus. 35.1% of the early group and 34.8% of the late group did not have an angle between 0 degrees and 10 degrees , the thresholds set for re-operation. For ratio of the visual acuities (remaining amblyopia) there was a small but significant advantage for the early group. There was hardly any correlation between the baseline parameters and the primary endpoints. Children scheduled for early surgery had first been operated at 20 (SD 8.4) months, but 8.2% had not been operated at age six. Children scheduled for late surgery had been operated at 49.1 (SD 12.7) months, but 20.1% had not been operated at age six. The number of operations per child was 1.18 (SD 0.67) in the early and 0.99 (SD 0.64) in the late group. Age at recruitment, age that strabismus reportedly had started and refraction at entry examination were similar among operated and non-operated children. Only the angle of strabismus at entry predicted, to some extent, whether a child had been operated at age six. DISCUSSION: Children operated early had better gross stereopsis at age six as compared to children operated late. They had been operated more frequently, however, and a substantial number of children in both groups had not been operated at all.     

Effects of an infratrochlear nerve block on reducing the oculocardiac reflex during strabismus surgery: a randomized controlled trial

Graefe's Archive for Clinical and Experimental Ophthalmology - To determine whether an infratrochlear nerve block (ITB) can reduce the oculocardiac reflex (OCR) during strabismus surgery on the...     

Adjustable and non-adjustable strabismus surgery: a retrospective case-matched study

Adjustable suture strabismus surgery was introduced to improve results in unpredictable strabismus cases. However, its usage is increasing and in some centres is routine. The present authors propose that the routine use of the adjustable suture technique can only be justified if it can be shown to confer an advantage to the patient. In a retrospective analysis of matched data, they compared the results of their adjustable with non-adjustable strabismus surgery. The adjustable suture procedures performed during a 5-year period, on non-thyroid eye disease patients, were matched to non-adjustable cases according to the type and aetiology of strabismus and the magnitude of deviation. Pairs were matched as closely as possible according to age and strabismus surgery history. All cases were incomitant. The surgical results of the two groups were analysed with regard to the pre-operative and post-operative angles of deviation, the post-operative drift, and a successful outcome, pre-defined by carefully selected criteria. Twenty-six cases were analysed in each of the two groups. Mean pre- and post-operative angles of deviation showed no significant difference between the two groups. 'Success' rates were 81% in the adjustable group and 88% in the non-adjustable group. Given that the success rate of the two techniques is similarly high, a much larger study is required to detect a difference in results, with statistical significance. The authors conclude that there is currently insufficient evidence that patients, without thyroid eye disease, benefit from the longer and potentially uncomfortable procedure of adjustable suture strabismus surgery to support its rapidly growing use and that a prospective randomised controlled trial is indicated.     

斜视手术前后双眼单视注视野的临床研究

目的　研究不伴弱视的斜视患者术前、术后双眼单视注视野的变化 ,并对双眼单视注视野检查评价双眼单视功能的意义进行探讨。方法　 (1 )斜视患者术前及术后进行同视机和Titmus立体图检查。 (2 )利用Bagolini线状镜分离双眼 ,通过弧形视野计检查斜视患者术前、术后双眼单视注视野。 (3 )对照组进行同视机、Titmus立体图和双眼单视注视野检查。结果　 (1 )术前内斜视病人及恒定性外斜视病人检查无双眼单视注视野 ,间歇性外斜视病人控制正位时存在双眼单视注视野 ,但不稳定 ,其范围与对照组比较无差异 ,术后所有斜视病人双眼单视注视野均存在 ,其范围与对照组比较无差异。 (2 )双眼单视注视野检查结果与同视机、Titmus立体图所查斜视病人双眼单视功能结果相一致。结论　利用Bagolini线状镜和弧形视野计检查双眼单视注视野可以从心理物理学方面了解斜视病人术前、术后在日常生活中双眼单视功能情况。该方法经济 ,简便 ,易行。临床上这种方法与其他检查方法相结合可以更全面地了解斜视病人术前、术后双眼单视功能情况。