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PEDIATRIC ANESTHESIA

Postoperative Analgesia in Children Undergoing Myringotomy and Placement Equalization Tubes in Ambulatory Surgery

Ana Lucia Pappas, MD^*, Elaine M. Fluder, RN MSN^*, Steve Creech, MS^*, Andrew Hotaling, MD, and Albert Park, MD

*Department of Anesthesiology, Department of Otolaryngology-Head and Neck Surgery, Loyola University Medical Center, Maywood, Illinois

Address correspondence to Ana Lucia S. Pappas, MD, Department of Anesthesiology, Loyola University Medical Center, 2160 S. First Ave., Maywood, IL 60153. Address e-mail to apappas{at}lumc.edu

	Abstract

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We enrolled 120 children undergoing bilateral myringotomy and tube placement in this prospective, randomized, observer-blinded study. Patients were randomized into one of four groups: Group 1 (control) was plain acetaminophen 10 mg/kg orally, Group 2 was acetaminophen 10 mg/kg with 1 mg/kg of codeine orally, Group 3 was transnasal butorphanol 25 µg/kg given immediately after the induction of anesthesia, and Group 4 was ketorolac 1 mg/kg given IM immediately after the induction of anesthesia. All children received oral midazolam (0.6 mg/kg) before surgery. A nurse blinded to the analgesic technique used assessed the child’s behavior at the induction of anesthesia and in the postanesthesia care unit using a 4-point scale. Analgesic effectiveness was determined by assessing the child’s pain at 5-min intervals using a modified 10-point objective pain scale. In the postanesthesia care unit, rescue pain medication was administered for an objective pain scale 4 or a behavior score 3. Our data suggest that IM ketorolac is a promising analgesic to be used in this surgical population. Time to first rescue analgesic was longest in the ketorolac group, and there was no associated postoperative vomiting or nausea. IM ketorolac given during surgery was the best analgesic regimen for these procedures.

IMPLICATIONS: We compared four different analgesics in the management of pain after placement of pressure equalization tubes during myringotomy in children and demonstrated that ketorolac or butorphanol provided superior analgesia when compared with acetaminophen with codeine or plain acetaminophen. Children who received ketorolac versus butorphanol had less vomiting in the 24 h after surgery.

	Introduction

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Bilateral myringotomy with placement of pressure equalization tubes (BMT) is one of the most common outpatient surgical procedures in children. Despite the brief duration of the procedure, the need for postoperative analgesia is well recognized. More than 70% of children undergoing BMT who do not receive preoperative analgesics will require pain medication in the early postoperative period (1). At this institution, BMT is most often performed without IV cannulation, and therefore, pain relief by an alternate route is required. In this study, we compared the efficacy of preoperatively administered IM ketorolac, intranasally administered butorphanol, and orally administered acetaminophen plus codeine to each other and to the response in a control group who received plain oral acetaminophen.

	Materials and Methods

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After approval from the IRB for the protection of human subjects, 120 children (aged 6 mo to 6 yr), ASA physical status I and II, who were scheduled for ambulatory BMT were enrolled in the study. Written, informed parental consent was obtained in all cases. Children who received analgesics 48 h before surgery or had an upper respiratory infection were excluded. Also excluded were children who required IV induction (e.g., malignant hyperthermia), history of opioid, aspirin, or nonsteroidal antiinflammatory drug allergy, renal insufficiency, bleeding disorders, or peptic ulcer disease. All children were kept nothing by mouth after midnight for solids. Liquids were permitted until 3 h before expected operating room time. Each child received oral midazolam 0.6 mg/kg (maximum dose 20 mg) for preoperative sedation 20–30 min before surgery.

The children were randomized into one of four groups by a computer-generated numbers table. The treatment groups were as follows; Group 1 (control) = acetaminophen 10 mg/kg oral elixir; Group 2 (A/C) = acetaminophen 10 mg/kg with codeine 1 mg/kg oral elixir (standard therapeutic preparation); and Group 3 (NB) = transnasal butorphanol 25 µg/kg. The IV preparation of butorphanol was used. If the volume to be administered was <0.5 mL, preservative-free saline solution was added to achieve a total volume of 0.5 mL to increase surface area contact. Group 4 (K) = ketorolac 1 mg/kg IM in the deltoid muscle immediately before surgery. Whereas previous studies have given ketorolac IV, it is not our, nor is it common, practice to start an IV or give medications IV without IV access (2). In Groups 1 and 2, the IV midazolam preparation was mixed with the study drug. In Groups 3 and 4, midazolam in an elixir form was administered, and the study drug was given immediately after anesthesia induction. General anesthesia was induced and maintained with sevoflurane in 100% oxygen by face mask technique.

A research nurse blinded to the study group collected the following variables: behavior scores at the induction of anesthesia and postanesthesia care unit (PACU) arrival; durations of anesthesia, surgery and PACU stay, severity of otitis media, and Aldrete recovery score (3). Postoperative behavior scores of the child (after being reunited with parents), time from arrival in PACU to accepting oral liquids, fit for home status, and episodes of vomiting and retching were also documented.

At the time of the induction of anesthesia and after arrival in the PACU, a behavior assessment was determined using a 4-point scale: 1 = calm and quiet; 2 = crying but consolable; 3 = crying but inconsolable; and 4 = agitated and thrashing (1). All BMTs were performed under the supervision of one of two attending surgeons (AHP and AJH) who graded the severity of otitis media on a numeric scale: 1 = no fluid, 2 = serous fluid, 3 = pus, and 4 = thick tenacious mucous.

On arrival to the PACU, each child’s pain was assessed and documented at 5-min intervals for up to 60 min using a modified 10-point objective pain scale, as described by Hannallah et al. (4). We substituted heart rate for blood pressure measurement using the same given score (0–2) because of difficulty in interpreting blood pressure readings in an agitated, moving child. A PACU nurse scored each child according to the Aldrete postanesthesia recovery score. As soon as the children were stable (Aldrete score >8), they were transferred to a Phase II step-down recovery in the PACU. Children who scored 4 in the modified Hannallah objective pain scale or had a postoperative behavior score 3 received an oral rescue dose of acetaminophen 10 mg/kg combined with codeine 0.5 mg/kg. Additionally, the time to first pain rescue was recorded.

Patients were discharged home when they were alert, pain free, and when parents felt comfortable taking them home. The minimum PACU stay at our institution is 1 h; therefore, no earlier discharges occurred.

A power analysis determined that group sizes of 30 each would achieve over 80% power to detect differences among the four percentages of 0.7%, 0.7%, 0.7%, and 0.35% versus the null hypothesis of equal percentages using a ² test at the 0.05 level of significance. The sample size calculations were performed using PASS2000 software.

All statistical analyses were performed using SPSS for Windows (SPSS 10.1; SPSS Inc, Chicago, IL) and S-plus for Windows (S-PLUS 2000 Professional Release 1; MathSoft, Inc, Seattle, WA). Descriptive statistics were calculated for all variables. The balance between treatment groups was demonstrated using the ² or Fisher’s exact test as appropriate for categorical variables and the Kruskal-Wallis test for continuous variables. The primary end-point of the percentage of patients requiring postoperative analgesics among the four treatment groups was compared using a ² test. Secondary analyses included Kruskal-Wallis tests to compare: (a) time to PACU discharge; (b) time from PACU admission to first oral liquid intake; and (c) Aldrete, behavior, and pain scores and oxygen saturation at PACU admission. Kaplan-Meier survival analysis (with a log-rank test) comparing time to first pain rescue medication among treatment groups was also used.

	Results

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One-hundred-twenty patients were enrolled in this study. One patient in Group 3 (NB) was dropped from the study because of a protocol violation. Thirty-five percent of the children were girls, and the average age for all patients was 2.2 yr. There were no statistically significant differences in weight, preoperative midazolam dose, behavior score at induction, heart rate at induction, total anesthesia and surgical times, or otitis media severity (Table 1).

	Discussion

Top Abstract Introduction Materials and Methods Results Discussion References

 
BMT is performed in approximately one million children annually in the United States, primarily in those with chronic or recurrent otitis media refractory to nonmedical treatment (5). Pain requiring analgesics in the postoperative period is common. Anesthesia for BMT, a very brief surgical procedure, is usually provided without IV access. Therefore, analgesic drugs are administered through other routes. This prospective, randomized study was undertaken to evaluate the analgesic efficacy of four different drugs administered via non-IV routes.

Our data revealed that acetaminophen plus codeine, butorphanol, and ketorolac were all superior to acetaminophen (control therapy) in providing postoperative analgesia. The latter two drugs were associated with better analgesia than the acetaminophen plus codeine. The two opioid-treated groups experienced a 25% incidence of vomiting at home on the first postoperative day; ketorolac-treated patients got the desired analgesia without associated vomiting.

Acetaminophen (10 mg/kg) plus codeine (1 mg/kg) and oral ketorolac (1 mg/kg) have been demonstrated to provide better postoperative analgesia than acetaminophen alone (1,7). Acetaminophen alone did not differ from placebo. Butorphanol transnasally administered has been used successfully in children (8). Butorphanol is a totally synthetic opioid agonist-antagonist analgesic and when transnasally administered, results in rapid central nervous system effects, perhaps by the rapid absorption at the capillary bed. In a dose finding study, Bennie et al. (7) found that 25 µg/kg of butorphanol transnasally administered produced a significant decrease in the need for postoperative analgesia after BMT versus placebo. Oral ibuprofen (10 mg/kg) compared with acetaminophen (15 mg/kg) offered no benefit over placebo after BMT procedures (9). However, ketorolac (1 mg/kg) compared with acetaminophen (15 mg/kg), both given orally before surgery, produced lower pain scores in the immediate postoperative period but with no lasting analgesic effect (10). That study concluded that the small benefit of ketorolac did not justify the cost. Since starting our investigation, Galinkin et al. (11) has shown that fentanyl 2 µg/kg intranasally provided safe serum concentrations by blood samples drawn at emergence and in the PACU. These children also showed diminished postoperative agitation without an increase in vomiting, hypoxemia, or increased discharge times when compared with placebo after sevoflurane or halothane anesthetics.

Our study had some limitations. We were not able to use a true placebo because parents would not agree to no analgesia for their children. Nevertheless, use of acetaminophen alone provided totally inadequate analgesia compared with the other regimens and served well as a surrogate control placebo. Further, we had to modify the objective pain scale devised by Hannallah et al. (4) because, in children this age who were sometimes agitated in the recovery room, taking repeated blood pressures was not productive. Thus, we used heart rate as a surrogate for blood pressure. We believe this one deviation from their protocol was not relevant to our findings because we did regularly take blood pressures in each patient, and the unreported data of successful readings correlated exactly with changes in heart rate.

In conclusion, our data suggest that ketorolac 1 mg/kg given IM provides superior analgesia to placebo and acetaminophen with codeine for BMT. Whereas its analgesic properties were not better than those seen with butorphanol, ketorolac was associated with less vomiting in the first 24 hours after surgery. A comparison with transnasal fentanyl may be warranted. However, based on our data, ketorolac given IM after an anesthesia induction may be the best regimen for postoperative analgesia for the BMT procedure.

	Acknowledgments

 
I gratefully acknowledge and appreciate the comments and suggestions made by Dr. Stephen Slogoff and Dr. W. Scott Jellish.

	References

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1. Watcha MR, Ramirez-Ruiz M, White PF, et al. Perioperative effects of oral ketorolac and acetaminophen in children undergoing bilateral myringotomy. Can J Anaesth 1992; 39: 649–54.[Abstract/Free Full Text]
2. Davis PJ, Greenberg JA, Gendelman M, et al. Recovery characteristics of sevoflurane and halothane in preschool-aged children undergoing bilateral myringotomy and pressure equalization tube insertion. Anesth Analg 1999; 88: 34–8.[Abstract/Free Full Text]
3. Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg 1970; 49: 924–33.[Free Full Text]
4. Hannallah RS, Broadman LM, Belman BA, et al. Comparison of caudal and ilioinguinal/iliohypogastric nerve blocks for control of post-orchiopexy pain in pediatric ambulatory surgery. Anesthesiology 1987; 66: 832–4.[ISI][Medline]
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6. Tobias JD, Lowe S, Hersey S, et al. Analgesia after bilateral myringotomy and placement of pressure equalization tubes in children: acetaminophen versus acetaminophen with codeine. Anesth Analg 1995; 81: 496–500.[Abstract]
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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (5) Citing Articles via Google Scholar Google Scholar Articles by Pappas, A. L. Articles by Park, A. Search for Related Content PubMed PubMed Citation Articles by Pappas, A. L. Articles by Park, A. Related Collections Surgery Pediatrics Ambulatory Airway

Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999