Intranasal steroids in adenoid hypertrophy and sleep disordered breathing in children

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Intranasal steroids in adenoid hypertrophy and obstructive sleep apnea

Presented by Suparat Sirivimonpan, MD.

November23, 2012

Suparat Sirivimonpan, MD.

Published in: Health & Medicine
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Intranasal steroids in adenoid hypertrophy and sleep disordered breathing in children

  1. 1. Suparat Sirivimonpan,MD. 23/11/2012
  2. 2. Intranasal corticosteroid(INS)• since 1974• extremely effective in reducing the nasal symptoms of sneezing, itching, rhinorrhea, and nasal congestion• firstline treatment choice for patients with rhinitis, esp. persistent or more severe symptoms• effective treatments for – AR,NAR , rhinosinusitis, and nasal polyposis – Adenoid hypertrophy?? , Snoring??, OSA ?? • nasal and oropharyngeal mucosal inflammation is present in patients with OSAS Allergy 2008: 63: 1292–1300 Immunol Allergy Clin N Am 31 (2011) 545–560
  3. 3. OSAS (obstructive sleep apnea syndrome)• disorder of breathing during sleep characterized by – prolonged partial upper airway obstruction – and/or intermittent complete obstruction (obstructive apnea) – that disrupts normal ventilation during sleep and normal sleep patterns• prevalence of OSAS (Children) in the range of 1-5% (relatively common disease)• obesity being an independent risk factor Pediatrics 2012;130:e714–e755
  4. 4. Pediatrics 2012;130:e714–e755
  5. 5. Seminars in Anesthesia, Perioperative Medicine and Pain (2006) 25, 109-116
  6. 6. Otolaryngol Clin N Am 45 (2012) 1055–1069
  7. 7. OSAS• Adenotonsillar hypertrophy is the most common cause of OSAS• adenotonsillectomy (AT) : primary treatment  recurrence• postoperative PSG should be performed to ensure that OSAS has resolved• postoperative complications : haemorrhage, airway obstruction secondary to edema, prolonged muscular paralysis and palato-pharyngeal insufficiency The Cochrane Library 2010, Issue 10 Pediatrics 2012;130:e714–e755
  8. 8. OSAS• CPAP was effective in the treatment of OSAS, but adherence is a major barrier• In less severe cases, non-surgical interventions may be considered, however few medical alternatives are currently available The Cochrane Library 2010, Issue 10 Pediatrics 2012;130:e714–e755
  9. 9. Momethasone Furoate
  10. 10. Pediatrics 2007;119;e1392
  11. 11. • 2-stage, randomized, placebo-controlled trial • 60 children : AH and referred for exclusive adenoidectomy Exclusion criteria : -concomitant tonsillar hypertrophyInclusion criteria -positive history of allergy or atopy(1) adenoid pad occluding 75% of -URI within the past 2 weeksnasopharynx(nasal endoscopy) -nasal anatomic anomalies(2) age between 3 and 7 years -sinonasal diseases (ex. polyposis)(3) symptoms consistent with AH -craniofacial malformationslasting 12 months -genetic diseases(4) no previous adenoidectomy -neurologic disorders -cardiovascular diseases -immunodeficiency -history of epistaxis -hypersensitivity to steroids -intranasal, topical, or systemic steroid or Pediatrics 2007;119;e1392 antibiotic treatment within the past 4 weeks
  12. 12. 60 patients group A group B first stage 30 patients 30 patients Mometasone (50 mcg/nostril/day) placebo 40 days assessment 3 patients did not complete the study 1: systemic steroid (acute ethmoiditis) Nonresponders and placebo-treated 1 : lost to follow-up monitoring Patients  adenoidectomy 1 : dropped out Responders (21 27pts) (77%)second stage group A1 group A2 11 pts 10 pts MF alternate days , daily MF , 3 months first 2 weeks per month first 2 weeks per month Pediatrics 2007;119;e1392
  13. 13. • physical evaluation and nasal endoscopy• clinical history – parents with a questionnaire – age, gender, weight, history and family history of atopy or allergy, and use of drugs• Symptoms such as nasal obstruction, rhinorrhea, cough, snoring, and obstructive sleep apnea were also – clinical scoring system ranging from 0 to 3 – (0 absent; 1 occasional; 2 frequent; 3 daytime and nighttime symptoms) – score related to severity• parents reported on their children’s symptoms and eventual adverse effects (eg, nasal bleeding)• Compliance with drug administration was assessed biweekly in telephone interviews with parents Pediatrics 2007;119;e1392
  14. 14. No patient-personal or family history of allergy or atopy-undergone previous surgery-received any drugs in the past 4 weeks-immunodeficiencies Pediatrics 2007;119;e1392
  15. 15. • chronic nasal obstruction improved significantly in group A (mean overall symptom score: 3)• unchanged in group B (mean overall symptom score: 9)• Adenoid size also decreased significantly in patients given MF (mean choanal obstruction: 64%) Pediatrics 2007;119;e1392
  16. 16. it is difficult to attribute the true value to theseresults because of the small number of patients studied Pediatrics 2007;119;e1392
  17. 17. • no significant differences in symptom scores were observed between the 2 subgroups (A1,A2)• mean choanal obstruction in group A2 was less than that in group A1 (56% vs 65.5%;P .001)• daily administration of MF for 2 weeks per month seems to decrease AH further• only 1 complication (episodic epistaxis)• Compliance with therapy during the last 3-month period was satisfactory in both subarms
  18. 18. Conclusion• Topical intranasal MF therapy can be considered a good therapeutic option to decrease AH• Nasal administration is safe, reproducible, easily performed, and well tolerated by pediatric patients• Daily use for 2 weeks per month after an initial 40-day-period treatment seems to be the ideal maintenance schedule• indications for adenoidectomy remain unchanged for nonresponders
  19. 19. International Journal of Pediatric Otorhinolaryngology (2008) 72, 1171—1175
  20. 20. 60 patients group A group B first stage 30 patients 30 patients Mometasone (50 mcg/nostrilday) placebo 40 days assessment 3 patients did not complete the study 1: systemic steroid (acute ethmoiditis) Nonresponders and placebo-treated 1 : lost to follow-up monitoring Patients  adenoidectomy 1 : dropped out Responders (21 27pts) (77%)second stage group A1 group A2 11 pts 10 pts MF alternate days , daily MF , 3 months first 2 weeks per month first 2 weeks per month Pediatrics 2007;119;e1392
  21. 21. • maintenance therapy : MF aqueous nasal spray (50 mcg) in each nostril daily for first 2 weeks of every month• During follow-up visits, parents or legal guardians reported – duration of maintenance therapy – eventual adenoid surgical treatment• Based on this information, divided into 3 subgroups: (1) children voluntarily suspending maintenance therapy and requiring surgery (Group A) (2) children continuing maintenance therapy but needing surgery (Group B) (3) children continuing maintenance therapy but not undergoing surgery (Group C) International Journal of Pediatric Otorhinolaryngology (2008) 72, 1171—1175
  22. 22. • assessment performed after first 4 months of treatment (previous trial)  clinical and endoscopic baseline• clinical picture including nasal obstruction, rhinorrhea, cough, snoring, and obstructive sleep apnea, and adenoid size were evaluated before the surgical procedure and at the last follow-up visit in the surgical groups• clinical and/or endoscopic evaluation – Nasal chronic obstructive symptoms : clinical score (0-3) – AH size was assessed by means of nasal endoscopy International Journal of Pediatric Otorhinolaryngology (2008) 72, 1171—1175
  23. 23. • 21 children : responders - included in study• 12 males and 9 females• mean age of 7±1.6 years International Journal of Pediatric Otorhinolaryngology (2008) 72, 1171—1175
  24. 24. A : surgery , no INS : 6 ptsGroup A : voluntarily suspended maintenance therapy within a few B : INS and Surgery : 3 ptsmonths (range: 1—3 months) after the first period of treatment C : INS , no surgery : 12 ptsGroup B : - 2 adenoidectomy , 1 patients adenoidectomy combined with transtympanicdrainage - nasal endoscopic examination revealed mild AH close to the Eustachian tube- Chronic obstructive nasal symptoms and adenoid pad size were unchangedcompared to baseline dataGroup C : - further significant improvement -Maintenance therapy was stopped definitively after a mean period treatmentof 23 months (range: 15—31 months) International Journal of Pediatric Otorhinolaryngology (2008) 72, 1171—1175
  25. 25. • Intranasal MF treatment was broken off due to poor compliance by parents or legal guardians (group A) – significant worsening of nasal chronic obstructive symptoms and an increase of adenoid size  surgical treatment• regular continuity  successful results• longterm therapy is safe and well tolerated by pediatric patients – No side effects were observed after a mean follow-up of 28 months (range: 6—36 months)• A multicenter, prospective, randomized study is warranted to confirm definitively the efficacy of nasal MF International Journal of Pediatric Otorhinolaryngology (2008) 72, 1171—1175
  26. 26. mometasone furoateClinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  27. 27. • prospective, observational study• 2-11 year-old children• Sleep-disordered breathing (SDB) : ranging from primary snoring to OSASInclusion criteria• 1) history of habitual snoring for the last 3 months or longer• 2) adenoid hypertrophy confirmed with simple X-ray findings or endoscopic examination by otolaryngologistExclusion criteria• 1) presence of symptoms of acute respiratory infection• 2) use of nasal or systemic corticosteroid or antibiotics within 4 weeks prior to the study• 3) prior tonsil or adenoid surgery• 4) history of craniofacial, neuromuscular, or genetic disorders Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  28. 28. • All patients received 4 weeks course of single intranasal administration in each nostril with mometasone furoate (100 μg)• Assessment : – history and physical examination (BW,height) – parental questionnaire (OSA-18) – sinus Xray, adenoid X-ray – skin prick test or Pharmacia CAP system for detecting allergy• Allergic rhinitis was diagnosed in case that each child complaining typical allergic symptoms showed positive result in allergic test• After 4 weeks course  re-assess Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  29. 29. Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  30. 30. Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  31. 31. Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  32. 32. Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  33. 33. • presence of allergy (P=0.065) and obesity (P=0.851) didn’t affect the effect of nasal steroid on total OSA-18 score• no significant change in body weight between before and after treatment (P=0.954)• Change in OSA-18 score showed no significant difference according to presence of sinusitis (P=0.488) Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  34. 34. Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  35. 35. Limitation• could not have a control group due to lack of consent• didn’t confirm the increased nasal airway patency with objective tool – under 5 years old  impossible to get patient’s cooperation during acoustic rhinometry Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  36. 36. Conclusion• 4-weeks course of INS (mometasone furoate) can be a effective treatment option in pediatric SDB patients without significant complications• this treatment works effectively regardless of allergic status, sinusitis, and obesity• improvement in quality of life of SDB children is due to not only decreased AN ratio but also other factors such as increase nasal airway patency• Considering this result, intranasal steroid can be used in SDB children regardless of allergic status or sinusitis Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011
  37. 37. International Journal of Pediatric Otorhinolaryngology 76 (2012) 829–831
  38. 38. • study aims : – compare the effect of environmental prophylaxis and nasal saline douching to nasal mometasone furoate in children with adenoid hypertrophy, regarding: • improvement of specific respiratory and nasal symptoms • objective reduction of adenoid tissue area• Children aged 4–8 years with previous diagnosis of adenoid hypertrophy International Journal of Pediatric Otorhinolaryngology 76 (2012) 829–831
  39. 39. • Inclusion criteria – symptoms of nasal obstruction and snoring and previous nasoendoscopy or lateral X-ray suggestive of adenoid hypertrophy• Exclusion criteria – use of topical or systemic corticosteroid, antihistamine or antibiotics for at least 2 months at first consultation – viral or bacterial upper airways infection at the previous month – Immunodeficiency – patients with nasal septal deviation – systemic diseases, such as cystic fibrosis or facial malformation International Journal of Pediatric Otorhinolaryngology 76 (2012) 829–831
  40. 40. 0 (absent)• questionnaire on the symptoms nasal obstruction, snoring, 1 (mild) rhinorrhea, sneezing and itching main purpose of this study design was to 2 (moderate) 3 (severe) minimize the interference of confusing• all the children : prick test for respiratorymacro-environment factors external allergens, nasoendoscopy (such as home, school, habits and exposure to allergens) NSS douching + environmental prophylaxis (general and specific allergens) 40 days symptoms questionnaire and to nasoendoscopy topical mometasone furoate (50 mcg/(nostril day) 40 days symptoms questionnaire and adenoid area in relation to to nasoendoscopy the nasopharyngeal area International Journal of Pediatric Otorhinolaryngology 76 (2012) 829–831
  41. 41. • 60 children were initially selected• 51 concluded the study – 34 (66.6%) males VS 17 (33.3%) females – Mean age (SD) was 6.43±1.47 – 24 patients (47.05%) : positive prick test to at least one allergen, – 27 (52.95%) : non-atopic International Journal of Pediatric Otorhinolaryngology 76 (2012) 829–831
  42. 42. MF significantly decreased from prior treatment and after saline douching (obstruction and snoring)severe obstruction International Journal of Pediatric Otorhinolaryngology 76 (2012) 829–831
  43. 43. MF significantly decreased from prior treatment and after saline douching (obstruction and snoring)moderate irritative nasal symptoms International Journal of Pediatric Otorhinolaryngology 76 (2012) 829–831
  44. 44. NSS irrigation : reduction was not MF : significantly lower thansignificantly different from that detected at the other twobefore treatment time points International Journal of Pediatric Otorhinolaryngology 76 (2012) 829–831
  45. 45. ConclusionNasal douching and environmental prophylaxis• Significantly improved nasal symptoms, snoring and all related symptoms due to improved nasal clearance, decreased mucosal edema and increased nasal permeability.• but did not influence on adenoid tissue areaMometasone furoate•additionally improved clinical symptoms and reduced adenoidhypertrophy when compared to exclusive nasal saline douchingcombined with environmental prophylaxis;•also significantly reduced the adenoid area in relation to thenasopharynx, in an objective evaluation
  46. 46. • prospective, randomized, placebo-controlled studyInclusion criteria• adenotonsillectomy-indicated patients• having symptoms associated with adenoid hypertrophy for at least 6 months International Journal of Pediatric Otorhinolaryngology 74 (2010) 773–776
  47. 47. Exclusion criteria• adenoidectomy previously• URI or allergic rhinitis or turbinate hypertrophy• had taken intranasal topical or systemic steroid in the last 1 year• taken any intranasal medical treatment• history of chronic nose-bleeding• Immunodeficiency• history of hypersensitivity, positive allergy or atopy against fluticasone• tonsillar hypertrophy• chronic otitis media with effusion• anatomic deformity in noise or sinonasal diseases• Craniofacial abnormalities such as cleft lip/cleft palate• genetic diseases (Down Syndrome)• neurological diseases• cardiovascular diseases International Journal of Pediatric Otorhinolaryngology 74 (2010) 773–776
  48. 48. • randomly divided into two groups – fluticasone propionate nasal drops of 400 mcg/day for 8 weeks (NSD- nasal steroid drop) – normal saline (NS) in the same way• follow-up every 4 weeks• No patient discontinuation occurred during the study International Journal of Pediatric Otorhinolaryngology 74 (2010) 773–776
  49. 49. • symptoms of nasal airway obstruction were assessed (0,8 wk)• fiberendoscopic images or rigid nasal endoscopic images• using the nasal passage way, choanal openings from top to bottom were graded (grade 1–4) – 1st grade: only top segment of choana is obstructed <%25 – 2nd grade: upper half of the choana is obstructed <%50 – 3rd grade: lying to the rhinopharynx and tuba opening is partially obstructed <%75 – 4th grade: choana is almost completely obstructed International Journal of Pediatric Otorhinolaryngology 74 (2010) 773–776
  50. 50. International Journal of Pediatric Otorhinolaryngology 74 (2010) 773–776
  51. 51. • Before the treatment there was no statistically significant difference between the NSD and NS group• Statistically significant improvement (p < 0.05) was observed in the NSD treated group compared to the NS treated group International Journal of Pediatric Otorhinolaryngology 74 (2010) 773–776
  52. 52. no statistically significant difference observed between the twogroups, in terms of their tonsil size
  53. 53. NSD treatment• 19/25 patients(76%) : no longer a need for surgery• Adenoidectomy 3 patients (12%)• 3 patients (12%) were informed of their ongoing need for surgery but their parents refused the surgery declaring that NSD had sufficiently improved their conditionsNormal saline treatment• 16/20(80%) : need for surgery• 4 patients postponed their adenoidectomy at the request of their parents for further monitoring in spite of persistant surgical indication International Journal of Pediatric Otorhinolaryngology 74 (2010) 773–776
  54. 54. • Improvement in nasal airway obstruction symptoms – effect of intranasal corticosteroids on adenoid size – reduce soft tissues of inferior turbinate• Intranasal steroid in drop form provides a better spread in the nasal cavity and reaches the nasopharynx and pharynx faster• Disadvantages : application position is uncomfortable• No complaints regarding usage have been reported by the patients in this study• only 1 case of episodic nose-bleeding and 1 sneezing International Journal of Pediatric Otorhinolaryngology 74 (2010) 773–776
  55. 55. Conclusion• This method provides an effective alternative to surgical treatment in children with adenoid hypertrophy• Intranasal corticosteroids are well tolerated by children• however, the most appropriate drug, the most efficient dose and optimal treatment duration continue to be investigated and determined by way of further prospective and randomized studies International Journal of Pediatric Otorhinolaryngology 74 (2010) 773–776
  56. 56. Pediatrics 2008;122:e149–e155
  57. 57. • randomized, double-blind, crossover designInclusion criteria• Children 6-12 years• habitual snoring, and on initial overnight polysomnographic assessment (PSG-1) fulfilled the criteria for mild OSAS – AHI 3-7 per hour of TST – Or AHI of 2 per hour of TST but in the presence of a respiratory arousal index (RAI) of 2 per hour of TST and nadir oxygen saturation 85% Pediatrics 2008;122:e149–e155
  58. 58. Patients with a history of allergic rhinitis wereExclusion criteria also included• asthma that required chronic preventive therapy• hypersensitivity to budesonide• recent nasal trauma• nasal surgery or nasal septum perforation• Current therapy with drugs that interact with budesonide (erythromycin, clarythromycin, ketoconazole, and cimetidine)• known immunodeficiency or undergoing immunosuppressant therapy• craniofacial, neuromuscular, syndromic, or defined genetic abnormalities• URI; systemic corticosteroidtherapy; or antibiotic therapy in the 2 weeks before the initiation of the study• children who already had had T&A in the past 12 months Pediatrics 2008;122:e149–e155
  59. 59. topical budesonide (32mcg/puff/nostril [total 64 mcg]Total 62 placebo spray N=43 [saline]) OD 19 withdraw (14 placebo ,5 budesonide) 7 unwillingness to continue INS 6 marked improvement (5/6 budesonide) 6 decided to pursue T&A (all placebo) Pediatrics 2008;122:e149–e155
  60. 60. antihistaminic medicationsor immunotherapyfor allergic symptoms wasrecorded for 23 children Pediatrics 2008;122:e149–e155
  61. 61. intranasal budesonide :-significant improvements in several PSG abnormalities, namely OAHI, RAI, and nadir SpO2-along with significant changes in some measures that pertain to sleep macroarchitecture, such as sleep latency, and thepercentage of TST spent in either slow-wave sleep or rapid-eye-movement sleep Pediatrics 2008;122:e149–e155
  62. 62. Significant reductions in adenoid size occurred with decreases in adenoidal nasopharyngeal ratio(N/P) ratio from 0.71±0.02 before treatment to 0.57±0.02 after 6 weeks of budesonide therapy(P .0001)54.1% children had normalization of their OAHI on the basis of currently accepted criteria (ie, OAHI 1 per hour of TST) Pediatrics 2008;122:e149–e155
  63. 63. • No differences in the responses to treatment either for – Obese versus nonobese children or – among children who had a history of allergic symptoms as compared with those who did not report any allergic problems Pediatrics 2008;122:e149–e155
  64. 64. 18no significant changes emerged during this follow-up period in PSGcharacteristics, degree of respiratory disturbance, or adenoid size Pediatrics 2008;122:e149–e155
  65. 65. • Intranasal budesonide administered during a period of 6 weeks to children with mild OSA effectively alleviated severity of respiratory disturbance, reduced size of adenoid tissues, and significantly improved, albeit slightly, some components of sleep architecture• discontinuation of the therapy for a period of 8 weeks did not seem to be associated with worsening of sleep or respiratory parameters Pediatrics 2008;122:e149–e155
  66. 66. study design Partici- Rx control duration outcome pantBerlucchi RCT , AH 60 1st ST: MF 1x1 1st ST: 1st stage: 40 Reduce in clinical 2007 2 stage (3-7 yr) 2nd ST: MF placebo days symptom score and daily 2 wks/mo 2nd ST: MF 2nd stage: 3 adenoid size alternate months days 2 wk/moYong Gi Prospec- SDB 41 MF 1x2 no 4 wk improve SDB, Jung tive (2-11 yr) physical symptom, 2001 adenoid sizeRenaldo Prospec- AH 51 1st ST : NSS+Env. no 4wk Reduce nasal 2012 tive (4-8 yr) 2nd ST : MF 1x1 4 wk symptom score and adenoid sizeDemirhan RCT AH 45 FP drop 400 NSS 8 wk Reduce nasal 2010 (4-16 yr) mcg/day obstruction, snoring, apnea, adenoid size Gozal RCT, Mild OSAS 62 BD 1x1 NSS 6 wk Improve respiratory 2008 crossover (6-12yr) disturbance, reduce adenoid size
  67. 67. Otolaryngology -- Head and Neck Surgery 2009 140: 139
  68. 68. Otolaryngology -- Head and Neck Surgery 2009 140: 139
  69. 69. Conclusion• The available evidence suggests that nasal steroids may significantly improve symptoms of nasal obstruction in children with adenoid hypertrophy• The effect of nasal steroids on adenoid hypertrophy appears to be a group effect, not specific to any particular steroid (MF,FP,BD,Beclo,flunisolide) (TA,FF??)• Nasal steroids appear to be safe and well tolerated in children  nonsurgical management option attractive• more robust high-quality randomized controlled studies are needed to confirm the results• focus on optimal duration of treatment, minimum effective dosage, long-term efficacy, and the safety of long-term maintenance therapy
  70. 70. Areas for Future Research• What is the optimal duration of intranasal steroid use?• All trials have been short-term with a short-term follow-up• Does the OSAS recur on discontinuation of therapy?• What is the efficacy of intranasal steroids in children who have chronic or atopic rhinitis?• How do the benefits and adverse effects of long-term nasal steroids compare with surgery?• Do they correlate with clinical outcomes or long-term prognosis?
  71. 71. Thank you

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