Eur Arch Otorhinolaryngol DOI 10.1007/s00405-014-2914-9
Miscellaneous
Pain after pediatric otorhinolaryngologic surgery: a prospective multi‑center trial Orlando Guntinas‑Lichius · Gerd Fabian Volk · Katharina Geißler · Marcus Komann · Winfried Meissner
Received: 11 December 2013 / Accepted: 23 January 2014 © Springer-Verlag Berlin Heidelberg 2014
Abstract The purpose of this study was to describe postoperative pain within the first day after pediatric otorhinolaryngologic surgery and to identify factors influencing postoperative pain. Using a prospective evaluation and a Web-based multi-center registry, children ≥4 years of age (n = 365) rated their pain using questionnaires of the project Quality Improvement in Postoperative Pain Treatment for Children including faces numeric rating scales (FNRS, 0–10) for the determination of patient’s pain on ambulation and his/her maximal and minimal pain within 8 h after day case surgery or at the first postoperative day for inpatient cases. Additionally, functional interference and therapyrelated side effects were assessed. Half of the children were 4 or 5 years of age. The predominant types of surgery were adenoidectomy and tonsillectomy ± ear ventilation tubes. Although analgesics were applied preoperatively, intraoperatively, in the recovery room and on ward, maximal pain within the first day after surgery reached 4.4 ± 3.3 (FNRS). Pain was highest after oral surgery, especially after tonsillectomy and nose surgery. 39 % of the children reported pain interference with breathing (39 %). The most frequent side effect was drowsiness (55 %). Multivariate analysis revealed that maximal pain was independently associated
Electronic supplementary material The online version of this article (doi:10.1007/s00405-014-2914-9) contains supplementary material, which is available to authorized users. O. Guntinas‑Lichius (*) · G. F. Volk · K. Geißler Department of Otorhinolaryngology, Jena University Hospital, Lessingstrasse 2, 07740 Jena, Germany e-mail:
[email protected]‑jena.de M. Komann · W. Meissner Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany
with the non-standardized use of opioids in the recovery room, or use of non-opioid or opioids on ward. Analgesia and perioperative pain management in pediatric otorhinolaryngologic surgery seems to be highly variable. Tonsillectomy and nose surgery are very painful. After otorhinolaryngologic surgery many children seem to receive less analgesia than needed or ineffective analgesic drug regimes. Keywords Postoperative pain · Pediatric surgery · Otolaryngology · Quality management · QUIPSI
Introduction Postoperative pain therapy is an important part of perioperative care and a fundamental right of any surgical patient including children. For adults it is known that appropriate management of postoperative pain reduces perioperative morbidity, complications, hospital stay, and costs [1]. In general, we know for adults that there seems to be a worldwide undersupply of adequate pain management after surgery [2, 3]. Recently, a prospective cohort study using data of 70,764 adult patients taking part in the Quality Improvement in Postoperative Pain Treatment (QUIPS) registry has shown that pain on the first postoperative day in adults is at a high level in many so-called minor procedures such as appendectomy, cholecystectomy, hemorrhoidectomy, and tonsillectomy [4]. The authors concluded that these patients perhaps are given less analgesia than needed. Next to tonsillectomy, many typical otorhinolaryngologic procedures are performed in children. In general, there is a lack of knowledge about pain and specific pain management after pediatric otorhinolaryngologic surgery [5]. Some older studies with small sample sizes suggest
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high levels of pain after otolaryngologic procedures in children, reported especially after tonsillectomy and adenoidectomy, as well as undertreatment of postoperative pain by physicians and parents [6–9]. As a consequence of the QUIPS project, an equivalent tool was developed and validated for children called QUIPSI (Quality Improvement in Postoperative Pain Management in Children) [10, 11]. Recently, a prospective single-center trial using QUIPSI has shown that maximal pain values within the first day after pediatric otorhinolaryngologic were significantly elevated. It was striking that a significant proportion of children received too infrequent and/or inadequate pain management [12]. In a next step, it is worthwhile to analyze if this is a monocentric problem or a common finding in other hospitals. Therefore, the present multi-center study used QUIPSI to analyze postoperative pain within the first day in children after any kind of pediatric otorhinolaryngologic procedures and pain management in numerous hospitals in German-speaking countries.
Materials and methods The present prospective cohort study was part of the German–Austria–Switzerland-wide Quality Improvement in Postoperative Pain Treatment in Children (QUIPSI) registry. The complete set of instructions, questionnaire, and forms in German language has been published recently [10, 12]. Briefly, QUIPSI is an ongoing multi-center, prospective, observational study. Institutional review board approval was obtained prior to study initiation by the University Ethics Committee of the Jena University Hospital, Thuringia, Germany. The parents of each patient entering the study signed their consent. The QUIPSI questionnaire consisted of two parts for each patient: The first part of the QUIPSI questionnaire addressed the child directly (Supplement Fig. 1). This part was given to the patient for day surgery cases on the afternoon of surgery (within 8 h) and for inpatient cases on the first postoperative day (within 24–30 h after surgery). After a standardized instruction of the parents and the child by a trained nurse or physician, the child completed the form in most cases with the help of the interviewer. Reading skills were not necessary. If the child was too young to read the questions himself, the questions were read to him. The Faces Pain ScaleRevised (FPS-R) from Hicks et al. [13] was a dominant tool of the questionnaire. In accordance with the FPS-R, faces numeric rating scales (FNRS) were used to estimate postoperative pain (minimal pain, maximal pain, pain on ambulation). Generally, from left to right, the faces and higher numbers indicated more pain. A further eight questions with checkboxes were related to pain-related
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interference, side effects, and pain management. This first part covered the outcome parameters of the questionnaire, whereas the second part, which is filled in by an investigator, covered the relevant process parameters. The usage of pain drugs on ward only was assessed if the drug was given prior to the questioning of the child. All data were made anonymous and transferred via Internet (http://www. quips-projekt.de/) to the external database for the benchmark project of QUIPSI. This feature allows each participating hospital an anonymous comparison to the results of other hospitals. All children participating in QUIPSI between February 2009 and July 2012 were included in the analysis. QUIPSI allowed the inclusion of children from 4 to 17 years of age admitted for pediatric surgery in the participating hospitals. By German law, the German procedure classification (OPS-301) has to be used by all German hospitals for coding of surgical procedures. Indication for day case surgery versus inpatient surgery is also ruled by law in Germany. To select standard pediatric otorhinolaryngologic procedures, all patients with the OPS codes 5–18 (ear surgery), 5–19 (middle ear surgery), 5–20 (miscellaneous middle ear or inner ear surgery), 5–21 (nose surgery), 5–22 (paranasal sinus surgery), 5–25 (tongue surgery), 5–26 (salivary gland surgery), 5–28 (nasopharyngeal or oropharyngeal surgery), 5–29 (pharyngeal surgery), 5–30 (laryngeal surgery), or 5–31 (miscellaneous laryngeal surgery or tracheal surgery) were selected. Furthermore, only patients were included when at least one of the three FNRS pain outcome measures was available. Statistics Children’s characteristics and QUIPSI variables were analyzed with IBM SPSS statistics software (Version 20.0) for medical statistics. Data are presented as mean ± standard deviation (SD) if not otherwise indicated. Analyses included Chi square test and non-parametric Mann–Whitney U test to compare the characteristics of those who consented versus those who declined (Table 1). Further analyses included Chi square test and non-parametric Kruskal–Wallis test to compare the four major categories of otorhinolaryngologic surgery (Table 2; Fig. 2). The group of patient with tonsillectomy was large enough to allow a benchmarking between the hospitals. The measured pain scores in the different hospitals were compared with the non-parametric Kruskal–Wallis test. All outcome and process parameters were then summarized descriptively (Table 3); associations among patients` characteristics and process parameters, respectively, and outcome parameters were examined via Pearson product-moment correlations (Tables 4, 5). Multivariate linear regression models with stepwise entry were generated for scaled FNRS pain
Eur Arch Otorhinolaryngol Table 1 Characteristics of included and excluded patients
Measure
All patients N = 461
Excluded patients N = 96
Body weight (kg), mean ± SD Body height (m) Body mass index (kg/m2) Duration of surgery, mean ± SD, min Age (years) 4 5 6 7 8 9 10–12 13–14 15–16 17–18 Unknown
175 86 60 25 23 21 33 19 6 7 6
109 75 53 23 17 20 32 17 6 7 6
66 11 7 2 6 1 1 2 0 0 0
Gender, n Male Female
254 207
195 170
59 37
ASA status, n 1 2 3 Unknown Type of surgery, n Ear surgery alone Ear and salivary gland surgery Ear and oral surgery Nose surgery Nose and oral surgery Oral surgery alone Neck surgery alone Laryngeal surgery alone If oral surgery: with tonsillectomy If oral surgery: with adenoidectomy Admission status, n Same day case Inpatient Unknown
parameters (Table 6). Multivariate binary logistic regression models with stepwise entry were generated for categorized pain management side effect parameters (Table 7). Patients’ characteristics and process parameters for regression analysis were derived from those suggestive for significant associations (P
