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Relative bioavailability and plasma paracetamol profiles of Panadol suppositories in children.

OBJECTIVE: To determine the relative bioavailability and plasma paracetamol concentration profiles following administration of a proprietary formulation of paracetamol suppositories to postoperative children. METHODOLOGY AND RESULTS: Study A-eight children undergoing minor surgery had blood samples collected following the rectal administration of either a 250 mg or 500 mg paracetamol suppository on one day and an equivalent oral dose on the following day. A mean dose of 13 mg/kg gave a mean Cmax (Tmax) of 7.7 mg/L (1.6 h) and 4.9 mg/L (2.0 h) following oral and rectal administration, respectively. The mean relative rectal bioavailability was 78% (95% confidence interval of 55-101%). Study B-20 children undergoing tonsillectomy and/or adenoidectomy were randomly assigned to receive a postoperative dose of 500 mg of paracetamol either as 2 x 250 mg liquid filled or 1 x 500 mg hard wax Panadol suppository. A mean dose of 25 mg/kg produced mean maximum plasma paracetamol concentrations of 13.2 mg/L and 14.5 mg/L at 2.1 and 1.9 h for the hard and liquid filled suppository, respectively. The absorption rate constants and areas under the curves suggested no difference in the rate or extent of absorption between the two formulations. CONCLUSION: Absorption of paracetamol following rectal administration of Panadol suppositories to postoperative children is slower and reduced as compared to oral therapy. The hard wax and liquid filled products have similar absorption characteristics. The usually quoted antipyretic therapeutic range for paracetamol is 10-20 mg/L, although 5 mg/L may be effective. A single rectal dose of 25 mg/kg will obtain this lower concentration within 1 h of administration and maintain it for up to 6 h. When given in an appropriate dose for analgesia, maximum plasma paracetamol concentrations would be available in the immediate postoperative period if the rectal dose was given 2 h before the planned end of the procedure.

Acetaminophen↗

Withholding oral fluids from children undergoing day surgery reduces vomiting.

The effect of withholding oral fluids on the incidence of postoperative vomiting was evaluated in 317 children undergoing day surgery. Children were randomized by cohort into one of two groups either drinking oral fluids or having oral fluids withhold for 4-6 h postoperatively. All patients received replacement intravenous fluids sufficient to cover the anticipated fasting period. Vomiting was assessed in hospital through to the first postoperative day. Compliance to the protocol was excellent. The incidence of vomiting in the group with fluids withheld was significantly less than (P < 0.004) that of the group which drank (38% vs 56%). This difference was seen whether or not patients thought to be at high risk for postoperative vomiting (strabismus or adenoidectomy +/- tonsillectomy) were included in the analysis. The greatest effect of withholding oral fluids was seen in patients receiving opioids (P < 0.001) where vomiting was reduced from 73% to 36%. Withholding oral fluids postoperatively from children undergoing day surgery reduces the incidence of vomiting.

Ambulatory Surgical Procedures↗

Treatment of obstructive sleep apnea in children: do we really know how?

Obstructive sleep apnea syndrome (OSAS) is a frequent, albeit underdiagnosed problem in children. If left untreated, OSAS may lead to substantial morbidities affecting multiple target organs and systems. The immediate consequences of OSAS in children include behavioral disturbance and learning deficits, pulmonary hypertension, as well as compromised somatic growth. However, if not treated promptly and early in the course of the disease, OSAS may also impose long-term adverse effects on neurocognitive and cardiovascular function, thereby providing a strong rationale for effective treatment of this condition. This review provides a detailed description of the current treatment modalities for pediatric OSAS, and uncovers the potential limitations of the available data on these issues. Furthermore, we postulate that OSAS will persist relatively often after tonsillectomy and adenoidectomy, and that critical studies need to be conducted to identify such patients and refine the clinical management algorithm for pediatric OSAS.

Anti-Inflammatory Agents↗

Guiding practice improvements in pediatric surgery using multidisciplinary clinical pathways.

Clinical pathways guide the evaluation and care of patient populations and can advance the strategic initiatives of the organization as well. To meet external and internal demands, this organization developed pathways to reduce variability in practice, integrate available evidence into care delivery, improve care coordination and documentation, increase efficiencies, and provide outcomes data to consumers and payers. The authors highlight processes and outcomes of some of the organization's surgical pathways, including guidelines for children with second degree burns grafted with TransCyte, those children hospitalized for tonsillectomy or adenoidectomy, appendectomies, atrial and ventricular septal defects, and percutaneous endoscopic gastrostomy or surgical gastrostomy procedures.

Appendectomy↗

["Fuldaer ventilation surgery"--a surgical concept in severe ventilation disorders of the middle ear].

BACKGROUND: This report presents the long-term results of a special surgical technique in cases of persistent severe dysfunction of the Eustachian tube. PATIENTS AND METHODS: We performed this operation on 16 patients (18 ears) between 1982 and 1997. Almost all patients had undergone previous surgery. This included myringotomies and tube insertions, adenoidectomies, tonsillectomies, myringoplasties and mastoidectomies, sinus surgeries, and an operation on a cleft palate. The concept developed by one coauthor (Draf) combines different methods to improve ventilation of the middle ear and protect the eardrum against partial vacuum. The concept combines mastoidectomy, posterior tympanotomy, and removal of the incus and the head of the malleus with an interposition of the incus. The tympanic membrane is then stabilized with a cartilage-perichondrium graft, and a tube is placed leading from the tympanic cavity to the nose (Wright-tube). A T tube may also be used. The procedure was varied slightly on occasion depending on intraoperative findings. RESULTS: Thirteen patients (15 ears) were available for audiometry at a minimum of 5 months after surgery until 14 years (mean duration of 6.2 years). We compared preoperative and postoperative air-bone gaps. They were measured for the three speech frequencies (500, 1000, and 2000 Hz) at 5 dB intervals. The average preoperative air-bone gap was 25.7 dB versus 18.2 dB postoperatively. This represents an improvement of 7.5 dB. Seven of fifteen ears required revision. Six ears required one revision procedure each (three for cholesteatoma, one for myringitis, one for discharge due to a narrow external auditory meatus, and one for mastoiditis). Another patient required three revision procedures (one for mastoiditis and the other two for cholesteatoma). CONCLUSION: This concept can help prevent cholesteatoma and improve hearing in more than 50 per cent of severe cases of dysfunction of the Eustachian tube.

Adolescent↗

[Long-term results of laser-tonsillotomy in obstructive tonsillar hyperplasia].

BACKGROUND: Carbon-dioxide-laser-tonsillotomy is reconsidered as a procedure to relieve patients in early childhood from obstructive symptoms caused by tonsillar hyperplasia such as snoring or sleep apnea without influencing the immunological function. METHODS AND PATIENTS: The protruding part of the tonsils was removed by a CO (2)-laser delivering 10 - 15 W. During 1993 to 2003, 83 children received laser-tonsillotomy, combined with adenoidectomy 51 children were available for follow-up with a standard questionnaire. The parents were surveyed in average 39 months postoperatively. 5 patients required a subsequent tonsillectomy due to a recurrence of tonsillar hyperplasia. Histological investigations were done. 15 children were reevaluated by clinical examination. RESULTS: Most of the patients were relieved from obstructive symptoms. There was no occurrence of postoperative hemorrhage or peritonsillar abscesses. The histological investigations on the specimens from later performed tonsillectomy (n = 5) showed no evidence of scarring opened crypts. The clinical examination did not reveal any signs of chronic infections. CONCLUSION: The tonsillotomy by carbon-dioxide-laser appears as a suitable and safe technique for the treatment of tonsillar hyperplasia without severe throat infection in early childhood.

Airway Obstruction↗

[Von Willebrand syndrome--risk of hemorrhage in ENT interventions in childhood].

Von Willebrand's disease (vWD) is the most common inherited bleeding disorder. Typical clinical features such as bleeding after surgery or trauma might suggest the disease. We present a series of 24 patients with vWD treated between 1989 and 1992. Diagnosis was confirmed by a reduction in plasma factor VIII antigen concentration, reduction of ristocetin cofactor activity and reduced factor VIII activity. Seventeen of the patients underwent surgery (7 adenoidectomies, 8 tonsillectomies, 2 paranasal sinus operations) and received preoperative stimulation of von Willebrand factor (vWF) using DDAVP. This resulted in a rapid increase in plasma vWF concentration from an average of 56% before stimulation to 190% of the normal value after stimulation. A reduction of partial thromboplastin time from an average of 44.4 seconds to 34.4 seconds was observed following DDAVP. No bleeding complications or other side-effects occurred. Preoperative stimulation of vWF using DDAVP proved to be a safe method to reduce the risk of bleeding in patients with vWD undergoing surgery.

Adolescent↗

[Examination of 1,300 children for incidence and therapy of hearing disorders in pediatric speech disorders].

This study presents the results on 1305 children with speech disorders. The examination includes ENT-inspection, audiometry, speech-evaluations and if required, psychological tests. In 48% we found hearing losses, most frequently in the age up to four years. In 95% hearing losses were fluctuating about 20 decibels, caused by malfunction of the tube or by adenoids, not even in autumn and winter, but also all the year. In this case, fluctuating hearing function reduces the total hearing input over the year. In only 5% we found cochlear hearing loss. In hearing impaired children speech development was significantly more depressed in all dimensions in comparison to normal hearing children. This study does impressive demonstrate the necessity of follow-up microscopic evaluations of the tympanic membrane and audiometry as well as the consequence operative therapy including adenoidectomy and insertion of ventilation tubes. With this concept, only 37% of the children required speech therapy.

Acoustic Impedance Tests↗

Evaluation of sleep-disordered breathing in children.

OBJECTIVE: We evaluated changes in disease-specific quality of life (QOL) for children with sleep-disordered breathing (SDB). PATIENTS, DESIGN, AND SETTING: We conducted a cohort study in 69 children (age range, 6 months to 13 years; median age, 6.1 years) from a hospital-based pediatric otolaryngology practice in a metropolitan area. We used the OSA-18, an 18-item QOL survey with known test-retest reliability, internal consistency, and construct validity. Survey domains included sleep disturbance, physical suffering, emotional distress, daytime problems, and caregiver concerns. INTERVENTION: Tonsillectomy or adenoidectomy was performed as part of routine clinical care. The OSA-18 was completed at entry by the child's caregiver and again at least 4 weeks after surgery. MAIN OUTCOME MEASURES: The validity of the OSA-18 change score was assessed by comparison with multiple external constructs, including a validated measure of longitudinal change (OSD-6 survey). Responsiveness was assessed by the standardized response mean (SRM). RESULTS: The mean baseline OSA-18 survey score was 3.1 (SD, 0.9) of a maximum 7.0, with higher values indicating poorer QOL. Change scores were available for all children, with a mean interval between preoperative and postoperative surveys of 61 days (range, 42 to 92 days). The mean OSA-18 change score of 1.14 (SD, 0.71) showed significant correlation with tonsil size (r = 0.40), adenoid size (r = 0.31), OSD-6 change scores (r = 0.71), and the direct caregiver estimates of change (r = 0.34). OSA-18 change scores showed large responsiveness to change (SRM 1.44; 95% confidence interval, 1.16 to 69), with the most responsive domains being sleep disturbance, physical suffering, and caregiver concerns. Significant responsiveness was also demonstrated for the domains of daytime problems and emotional distress. CONCLUSIONS: The OSA-18 is a valid, reliable, and responsive QOL measure that combines the advantages of a discriminative and evaluative survey in a single instrument. The OSA-18 is a useful measure of patient-based outcomes for clinical trials, health services research, and routine clinical care.

Adolescent↗

Complications of acute sinusitis in children.

Acute sinusitis is often a mild, self-limiting disease. However, in some cases, especially among children, sinusitis may become a severe, even life-threatening, disease. To examine the nature of complications of acute sinusitis, we studied the cases of children treated at the Helsinki University ENT Hospital, because of a complication caused by acute sinusitis from January 1997 to September 1998. There were 12 children (4 girls, 8 boys), whose ages ranged from 16 months to 16 years. One child had an epidural abscess, one got meningitis and cavernous sinus thrombosis, five had orbital cellulitis, one of whom lost her vision permanently in one eye, and five had preseptal cellulitis. All the children were treated with intravenous antibiotics and all, except the youngest, were treated with a direct sinus puncture. An operation (intranasal antrostomy, orbital drainage, functional endoscopic sinus surgery or adenoidectomy) was performed on six patients. In the majority of children, acute sinusitis is a mild self-limiting disease. However, severe complications still exist. When a complication of sinusitis is suspected, it is of utmost importance that the child be sent immediately to a hospital for proper diagnosis and treatment.

Acute Disease↗

Phagocytosis in the nasopharyngeal secretion by cells from the adenoid.

The aim of this study was to elucidate whether granulocytes and macrophages in surface secretion on the adenoid emanate from the adenoid and whether these cells participate in the control of the nasopharyngeal bacterial flora. Samples of the adenoid and its surface secretion were obtained during adenoidectomy from 12 children with recurrent acute otitis media, secretory otitis media or enlarged adenoids causing obstruction. Immunochemistry was used to examine the location of granulocytes and macrophages in the adenoid as well as the presence of IgA, IgM, IgG and plasma cells in the secretion. Phagocytosis in the secretion was examined in imprints stained with May Grünwald Giemsa. Acridine Orange and Gram staining were used to demonstrate the presence and location of bacteria in the secretion and mucosa. As a control, surface secretions were obtained from 12 children without any history of recurrent airway problems. Granulocytes and macrophages were observed in the epithelium of the adenoid and some of these cells penetrated the epithelial surface. Positive staining for IgA, IgM and IgG was observed in all secretions. In 10 of 12 children plasma cells were present in the secretion. Bacteria were observed in all imprints. With the exception of I child in each group phagocytosis of bacteria in the surface secretion was demonstrated from imprints in all children. We conclude that granulocytes and macrophages leave the adenoid and enter the surface secretion, where constant phagocytic activity takes place. The spatial relations between mononuclear and polymorphonuclear cells imply a possible cooperation between these cells in the overall control of the nasopharyngeal bacterial flora.

Adenoids↗

Does Helicobacter pylori colonize the nasopharynx of children and contribute to their middle ear disease?

OBJECTIVE: There is growing interest in studying the presence of HP in the upper aerodigestive tract. It was shown in several pilot studies that it colonizes the area, while other authors found no evidence of its presence there and a third group of authors believed that it had only a transient presence there. In this study we investigated a possible role for HP in middle ear disease in children. MATERIAL AND METHODS: Consecutive patients undergoing myringotomy and adenoidectomy for chronic otitis media with effusion or recurrent otitis media were enrolled. Middle ear fluids were cultured on three types of agar plate (Brucella + laked horse blood; Brucella + sheep blood; and chocolate). A double polymerase chain reaction (PCR) was run to detect urease-C and adhesion subunit genes. Rapid urease enzyme testing and PCR were used on the adenoid specimens. Parents were interviewed regarding symptoms suggestive of gastroesophageal reflux in their children. RESULTS: Eighteen patients were enrolled in the study (mean age 4.4 years; age range 3-8 years) with an equal gender distribution. All 28 middle ear fluid cultures were negative in all 3 media. Twenty-one of the 28 samples contained DNA, yet PCR revealed that none of them belonged to HP. Ten of the 13 adenoid specimens obtained were positive on rapid urease testing, but none on PCR. Seven of the 18 patients had at least 1 symptom suggestive of gastroesophageal reflux during the 6 months preceding the study but this did not have an impact on any of the results. CONCLUSION: There was no evidence from this study that Helicobacter pylori (HP) colonizes the nasopharynx of children with middle ear disease, whether dyspeptic or not. There is also no apparent role for this bacterium in middle ear pathology.

Adhesins, Bacterial↗

Epidemiology and treatment of otitis media with effusion in children in the first year of primary school.

In this multicentre study we evaluated the prevalence and risk factors of otitis media with effusion (OME) in Italian school-children and the effectiveness of medical treatment of chronic OME with a new cephalosporin, ceftibuten. During two winter periods, 3413 children, aged 5 to 7 years, were examined for the presence of OME by means of pneumotoscopy and a portable, hand-held tympanometer. The prevalence of asymptomatic OME was 14.2%, with no difference as regards sex, age, month of examination or geographic area. Younger children had significantly more bilateral than unilateral effusion. A recent episode of acute otitis media and previous tonsillectomy or adenoidectomy were associated with an increased risk of OME in multivariate logistic regression models. The presence of OME was unrelated to such factors as birthweight, prematurity, sibling or parental history of allergy, duration of daycare attendance, family history of ear infections. After 12 weeks, 26.6% of children with OME still had middle-ear fluid: 52 were randomized to ceftibuten (9 mg/kg q.d. for 14 days) and 59 to no treatment (nasal saline drops allowed). Children treated with ceftibuten had a significantly better resolution of middle-ear effusion after 4 and 8 weeks. As mass screening programmes for OME in the year of school entry are questioned, a focus only on children with known risk factors seems advisable. Ceftibuten can be useful in reducing the duration of middle-ear effusion.

Ceftibuten↗

Cow's milk allergy is associated with recurrent otitis media during childhood.

To determine whether cow's milk allergy (CMA) in infancy is associated with recurrent otitis media (ROM) or other chronic ear infections, we conducted a cohort study by enrolling 56 milk-allergic and 204 control schoolchildren. We also studied the association between ear problems and different atopic manifestations. A higher proportion of children with CMA had had ROM. defined as at least 15 acute otitis media episodes by the age of 10 years (27%, vs 12%, p = 0.009), and had undergone adenoidectomy and or tympanostomy compared with the controls (48%, vs 28%, p = 0.005). However, this was only true of the children who had developed respiratory atopy. Asthma and/or allergic rhinitis, but not atopic dermatitis, posed a significant risk for ROM, while all the three atopic manifestations enhanced the risk for secretory otitis media. Positive skin prick tests with food, but not with inhaled allergens, tended to be associated with ear problems. In conclusion, we found that children with CMA in infancy, even when properly treated, had experienced significantly more ROM, the risk associating with concomitant development of respiratory atopy.

Acute Disease↗

Immunoglobulin-secreting cells in the surface secretion on the pharyngeal tonsils.

As B-lymphocytes on the pharyngeal tonsils constitute a considerable part of the leukocytes in the surface secretion, and their biological role is obscure, we explored their possible function with respect to immunoglobulin production. Twenty children scheduled for routine adenoidectomy participated. Surface secretion from 10 children was analysed for presence of plasma cells and cells from the secretions of the other 10 children were tested in enzyme-linked immunosorbent spot assays (ELISPOT-assays) for their capacity to secrete and produce IgA, IgM and IgG. Plasma cells and cells that secreted IgA, IgM and IgG respectively were present in the secretions of all tested children. In eight of ten children the IgG immunocytes, Ig-producing blasts and plasma cells. outnumbered the IgA immunocytes. The number of immunoglobulin secreting cells (ISCs) was reduced by half or more in cell suspensions exposed to the reversible protein synthesis inhibitor cycloheximide. It is concluded that immunocytes that produce and secrete immunoglobulin are present in the surface secretion on the pharyngeal tonsils. The production represents an addition to the immunoglobulins transported to the secretion by the poly-Ig receptor and by passive diffusion. The results shed new light on the pathogenesis of mucosal infections in the upper airways.

Adenoids↗

Costs arising from otitis media.

Otitis media (OM) is one of the most common diseases of childhood, and causes both direct and indirect costs to families and to society. This study calculated the costs arising from OM among 736 day care children whose infections were prospectively monitored for up to 15 mo in 10 day care centres in the city of Oulu. The children in the survey had 1.5 attacks of acute OM per person year, made 2.1 visits to a physician (cost $US55 visit(-1)) and received 1.5 courses of antimicrobials (cost $24 course(-1)). Their parents were absent from work for 1.9 d per person year (cost $85 d(-1)). Either adenoidectomy ($890 operation(-1)) or tympanostomy ($740) was performed on 6% of the children and the overall costs of surgery were $80 per person year at risk. In total, each single attack of acute OM cost $228. The average annual costs per child younger than 2 y were $1040, those for children aged 2-3 y $283 and those for children older than 3 y $141. The cumulative costs from age 6 mo to 7 y were $2549 child(-1). When the attributable risk of OM at a day care centre is taken into account, in Finland, a country with about 5 million inhabitants, OM gives rise to total annual costs of $US138 million. OM leads to considerable expenses and even expensive preventive measures would be cost-effective.

Child↗

Thymic and adenotonsillar enlargement after successful treatment of malignancies.

Anterior mediastinal and adenoid masses in children after cessation of chemotherapy for malignant disease often cause a diagnostic problem. Differential diagnosis of thymic enlargement and adenoid hyperplasia from recurrence frequently poses a challenge both for the radiologist and the physician. In this study the authors evaluated 491 patients with different malignant tumors for thymic and adenoid hyperplasia. Thymic hyperplasia was seen in 18 patients (5 Hodgkin disease (HD), 5 non-Hodgkin lymphoma (NHL), 4 Wilms tumor, 2 germ cell tumor, 1 Ewing sarcoma, and 1 neuroblastoma), only adenotonsillar hyperplasia was seen in 6 patients, all with NHL, and both thymic and adenotonsillar hyperplasia were seen in 3 patients (1 HD, 2 NHL). In 5 patients, adenoid hyperplasia was proven by biopsy; 1 patient underwent to adenoidectomy. Their histopathologic investigation showed polyclonal follicular hyperplasia. The authors recommend that patients with thymic and/or adenotonsillar enlargement after successful treatment of their primary malignancy should be evaluated cautiously before an invasive procedure is planned.

Adenoids↗

Prophylaxis of postoperative vomiting in children undergoing tonsillectomy: a systematic review and meta-analysis.

Postoperative vomiting (POV) remains one of the commonest causes of significant morbidity after tonsillectomy in children. A variety of prophylactic anti-emetic interventions have been reported, but there has only been a limited systematic review in this patient group. A systematic search was performed by using Cochrane Controlled Trials Register, MEDLINE and EMBASE to identify double-blind, randomized, placebo-controlled trials of prophylactic anti-emetic interventions in children undergoing tonsillectomy, with or without adenoidectomy. The outcome of interest was POV in the first 24 h. Summary estimates of the effect of each prophylactic anti-emetic strategy were derived using fixed effect meta-analysis. Where appropriate, dose-response effects were estimated using logistic regression and 22 articles were identified. Good evidence was found for the prophylactic anti-emetic effect of dexamethasone [odds ratio (OR) 0.23, 95% CI 0.16-0.33], and the serotinergic antagonists ondansetron (OR 0.36, 95% CI 0.29-0.46), granisetron (OR 0.11, 95% CI 0.06-0.19), tropisetron (OR 0.15, 95% CI 0.06-0.35) and dolasetron (OR 0.25, 95% CI 0.1-0.59). Metoclopramide was also found to be efficacious (OR 0.51, 95% CI 0.34-0.77). There is not sufficient evidence to suggest that dimenhydrinate, perphenazine or droperidol, in the doses studied, are efficacious, nor were gastric aspiration or acupuncture. In conclusion, dexamethasone and the anti-serotinergic agents appear to be the most effective agents for the prophylaxis for POV in children undergoing tonsillectomy.

Antiemetics↗