Samia N. Khalil

A comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures

Two identical, randomized, double-blind, placebo-controlled studies enrolled 2061 adult surgical outpatients at high risk of postoperative nausea and vomiting (PONV) to compare IV ondansetron 4 mg with droperidol 0.625 mg and droperidol 1.25 mg for the prevention of PONV. The antiemetic drugs or placebo were administered IV 20 min before the induction of anesthesia with a barbiturate compound, followed by maintenance with N2 O/isoflurane/enflurane. Nausea, emetic episodes, adverse events, and patient satisfaction were analyzed for the 0 to 2 h and 0 to 24 h postoperative periods. In the 0 to 2 h postoperative period, there was a complete response (no emesis or rescue antiemetic) in 46% of subjects given placebo (P < 0.05 versus antiemetic groups), in 62% given ondansetron, in 63% given droperidol 0.625 mg, and in 69% given droperidol 1.25 mg (P < 0.05 versus ondansetron). In the 0 to 24-h postoperative period, there were no significant differences in complete response between the ondansetron and droperidol 0.625 or 1.25 mg groups; all groups remained superior to placebo. The proportion of patients without nausea during the 0 to 24 h postoperative period was greater in the antiemetic groups compared with the placebo group; however, droperidol 1.25 mg was more effective than ondansetron 4 mg or droperidol 0.625 mg (43% vs 29% or 29%, respectively). Headache incidence was higher in the ondansetron group compared with either droperidol group. Patient satisfaction scores did not differ significantly among antiemetic treatment groups, although all were superior to placebo. In conclusion, all antiemetic treatment regimens were superior to placebo for the prevention of PONV in the immediate postoperative period; however, droperidol 1.25 mg was more efficacious than ondansetron during the early recovery period (0-2 h). There were no significant differences between ondansetron and either droperidol dose for emesis prevention during the 0 to 24 h postoperative period. Implications: More than 2000 patients at high risk of post-operative nausea and vomiting were given either placebo, ondansetron 4 mg, or droperidol 0.625 mg or 1.25 mg IV before the administration of general anesthesia. After surgery, the incidence of nausea, vomiting, medication side effects, and patient satisfaction were evaluated for 24 h. Droperidol 0.625 or 1.25 mg IV compared favorably with ondansetron 4 mg IV for the prevention of postoperative nausea and vomiting after ambulatory surgery. (Anesth Analg 1998;86:731-8)

Caudal block in children: ropivacaine compared with bupivacaine.

BACKGROUND Bupivacaine provides reliable, long-lasting anesthesia and analgesia when given via the caudal route. Ropivacaine is a newer, long-acting local anesthetic that (at a concentration providing similar pain relief) has less motor nerve blockade and may have less cardiotoxicity than bupivacaine. METHODS In a double-blind trial, 81 healthy children, undergoing ambulatory surgical procedures, were randomly allocated to receive caudal analgesia with either bupivacaine or ropivacaine, 0.25%, 1 mVkg. All blocks were placed by an attending anesthesiologist or an anesthesia fellow after induction of general anesthesia. RESULTS Data were available for 75 children. There were no significant differences between the two groups in baseline characteristics or in anesthesia, surgery, recovery room, or day surgery unit durations. The quality and duration of postoperative pain relief did not differ. Motor and sensory effects were similar. Time to first micturition did not differ. CONCLUSION Ropivacaine (0.25%, 1 ml/kg) provided adequate postoperative analgesia with no difference from bupivacaine (0.25%, 1 ml/kg) in quality and duration of pain relief, motor and sensory effects, or time to first micturition in our study children.

The antiemetic effect of lorazepam after outpatient strabismus surgery in children

The high incidence of postoperative emesis after strabismus surgery in pediatric outpatients can be reduced by the prophylactic administration of droperidol 75 micrograms/kg intravenously. However, this may be associated with profound sedation, delayed discharge, dysphoria, agitation, and extrapyramidal symptoms in this population. Because lorazepam used as an antiemetic in children during chemotherapy decreased the incidence of nausea and vomiting, we compared the antiemetic effects of lorazepam and droperidol in a randomized, double-blind, placebo-controlled study of 129 healthy children undergoing surgical correction of strabismus. The children, aged 1-13 yr, were randomly allocated into three groups. The children in group 1 received droperidol 75 micrograms/kg intravenously; those in group 2 received lorazepam 10 micrograms/kg intravenously; and those in group 3 received placebo. Anesthesia consisted of halothane, nitrous oxide in oxygen, and atracurium. Study drugs were administered intravenously after induction of anesthesia but before surgery. In children 3-13 yr old, administration of either lorazepam or droperidol was associated with a lower (P < 0.024) incidence of postoperative vomiting. There was no difference between the antiemetic effect of lorazepam and that of droperidol. The incidence of postoperative agitation was greater in the droperidol group (P < 0.001) than in the lorazepam and placebo groups. Postdischarge vomiting was less (P < 0.009) in children younger than 3 yr of age. Lorazepam, similar to droperidol, has an antiemetic effect in outpatient children 3-13 yr old undergoing strabismus correction, but it is associated with less postoperative agitation than is droperidol.

Ondansetron/promethazine combination or promethazine alone reduces nausea and vomiting after middle ear surgery

STUDY OBJECTIVES To determine the incidence of postoperative nausea and vomiting when a combination of ondansetron and promethazine is given prophylactically, and to ascertain the effect of postoperative nausea and vomiting on recovery room duration and patient satisfaction. DESIGN Prospective, randomized, placebo-controlled, double-blind study. SETTING University-affiliated tertiary-care hospital. PATIENTS 87 ASA physical status I and II adult patients scheduled for middle ear surgery. INTERVENTIONS Patients were randomly assigned to receive one of the following interventions intravenously: ondansetron 4 mg (Group 1), promethazine 25 mg (Group 2), ondansetron 2 mg plus promethazine 12.5 mg (Group 3, combination), or placebo (Group 4). MEASUREMENTS AND MAIN RESULTS Independent, study blinded observers recorded complaints of nausea and number of episodes of vomiting for 24 hours following the patients first response to commands. All patients were contacted the day after discharge to inquire about nausea and vomiting. The awakening time, postanesthesia care unit and day surgery unit durations, opioid use, and side effects were recorded. At the end of the 24-hour period, the study blinded observers asked patients for an overall assessment of their global anesthesia experience using an 11-point scale. During the 24-hour period, the incidence of postoperative nausea and vomiting was reduced from 74% (placebo) to 39% (promethazine; p = 0.03) and 29% (combination; p = 0.003). Compared with placebo, the severity of vomiting was significantly less in the combination group (p = 0.04). The number of very satisfied patients correlated negatively with the incidence of postoperative nausea and vomiting (p < 0.0001) and with the severity of vomiting (p = 0.003). CONCLUSION The prophylactic use of an antiemetic with middle ear surgery may reduce postoperative nausea and vomiting over 24 hours, and the ondansetron/promethazine combination or promethazine alone are cost-effective choices. Finally, the combination reduced significantly the severity of vomiting.

Intravenous ondansetron in established postoperative emesis in children

Background In pediatric postsurgical patients, postoperative vomiting is a common occurrence that can delay recovery and result in unplanned hospital admissions after outpatient surgery. This randomized, double‐blind, placebo‐controlled, multicenter study evaluated the efficacy and safety of ondansetron in the control of established postoperative emesis in outpatients aged 2–12 yr. Methods Screened for the study were 2,720 ASA physical status 1–3 children undergoing outpatient surgery during general anesthesia, which included nitrous oxide. Children experiencing two emetic episodes within 2 h of discontinuation of nitrous oxide were given intravenous ondansetron (n = 192; 0.1 mg/kg for children weighing less or equal to 40 kg; 4 mg for children weighing > 40 kg) or placebo (n = 183). Results The proportion of children with no emetic episodes and no use of rescue medication was significantly greater (P < 0.001) in the ondansetron group compared with placebo for both 2‐ and 24‐h periods after study drug administration (78% of the ondansetron group and 34% of the placebo group for 2 h; 53% of the ondansetron group and 17% of the placebo group for 24 h). Among patients with at least one emetic episode or with rescue medication use, the median time to onset of emesis or rescue was 127 min in the ondansetron group compared with 58 min in the placebo group (P < 0.001). The median time from study drug administration until discharge was significantly shorter (P < 0.01) in the ondansetron group (153 min, range 44–593 min) compared with the placebo group (173 min, range 82–622 min). The incidence of potentially drug‐related adverse events was similar in the ondansetron (3% of patients) and the placebo (4% of patients) groups. Conclusion A single dose of ondansetron (0.1 mg/kg up to 4 mg) is effective and well tolerated in the prevention of further episodes of postoperative emesis in children after outpatient surgery. Administration of ondansetron also may result in a shorter time to discharge.

Sublingual midazolam premedication in children: a dose response study

The purpose of this study was to evaluate various doses of sublingual midazolam premedication in children. In our prospective, double‐blind, placebo‐controlled trial, children (n=102, age range 12 to 129 months) scheduled for day surgery were randomized to receive either midazolam in one of three doses (0.25, 0.5, or 0.75 mg·kg−1) or placebo. Injectable midazolam was mixed with a thick grape syrup and placed under the tongue; the patient was asked to hold it as long as possible before swallowing. Children readily accepted the mixture. Analysing all patients randomized, none of the children receiving placebo vs 28% receiving 0.25 mg·kg−1 (P=0.02), 52% receiving 0.5 mg·kg−1 (P<0.001), and 64% receiving 0.75 mg·kg−1 (P<0.001) of midazolam showed satisfactory sedation (drowsy) at 15 min after administration. Children receiving the two higher doses of midazolam (0.5 and 0.75 mg·kg−1) accepted mask induction willingly, while the group receiving 0.25 mg·kg−1 resembled the placebo group (P<0.05).

A Double-Blind Comparison of Intravenous Ondansetron and Placebo for Preventing Postoperative Emesis in 1- to 24- Month-Old Pediatric Patients After Surgery Under General Anesthesia

We assessed the efficacy and safety of ondansetron (0.1 mg/kg IV) prophylactically administered before surgery for prevention of postoperative vomiting (POV) in a double-blind, placebo-controlled study of 670 pediatric patients, 1- to 24-mo-old, undergoing elective surgery under general anesthesia. The study enrolled 335 children in each treatment group (ondansetron versus placebo). Significantly fewer children treated with ondansetron exhibited emesis or discontinued the study prematurely after surgery (ondansetron, 11%; placebo, 28%; odds ratio = 0.33; P < 0.0001). The number required to treat prophylactically with ondansetron to prevent POV was approximately six. Ondansetron treatment also resulted in fewer patients requiring rescue medication or assumed to have had rescue upon early discontinuation from the study during the postoperative period (ondansetron, 5%; placebo, 10%) and less emesis (0 of 6) after rescue medication when compared with placebo (7 of 21). The incidence of POV and other antiemetic effects of ondansetron were similar in children aged 1–12 mo and 13–24 mo and in children prospectively expected or not expected to require opioids as part of their anesthetic or analgesic management. Ondansetron was well tolerated; the incidence of adverse events considered possibly related to study drug was similar between treatment groups (ondansetron, 1.8%; placebo, 1.5%).

Airway responses to desflurane during maintenance of anesthesia and recovery in children with laryngeal mask airways

Background:  We sought to characterize the airway responses to desflurane during maintenance of and emergence from anesthesia in children whose airways were supported with laryngeal mask airways (LMAs).

A paediatric trial comparing midazolam/Syrpalta mixture with premixed midazolam syrup (Roche)

Background: The bitter taste of midazolam is more acceptable to children when the drug is mixed with fruit juice or syrup. We use a thick grape syrup (Syrpalta), and children are sedated in 10–15 min. A premixed cherry‐flavoured midazolam solution (Roche), 2 mg·ml−1, is currently available. It has been our impression that the premixed midazolam has a slower onset of action. Our aim was to evaluate the effects of the midazolam mixtures (midazolam 0.5 mg·kg−1, 2 mg·ml−1) on childrens anxiety, sedation, separation anxiety, mask acceptance, and recovery time.

Successful intubation of a child with Goldenhar syndrome, who previously failed intubation, using an Airtraq.

ETT worked very well in this case, but we do not routinely recommend it because of the theoretical risk of having the end of the stylet advance too far into the endotracheal tube such that it becomes difficult to remove. In summary, we have used a novel supraglottic airway device, the AirQ ILA, as a conduit for fiberoptic intubation in two difficult intubation scenarios. We are currently evaluating its use in pediatric patients, both as a primary supraglottic airway and as a conduit for intubation. K A W S H A L A P E I R I S M I K E T R A Y N O R S I M O N W H Y T E BC Children’s Hospital Vancouver, BC, Canada (email: swhyte@cw.bc.ca)