Phase_NN1 1_CRD consisted_VVD of_PRF pre-procedure_AJ0 otoscopy_NN1 ,_PUN a_AT0 routine_NN1 ear_NN1 examination_NN1 with_PRP FLACC_NN1 evaluated_VVN from_PRP 30_CRD s_ZZ0 prior_AJ0 to_PRP the_AT0 speculum_NN1 entering_VVG the_AT0 ear_NN1 canal_NN1 until_PRP 60_CRD s_ZZ0 after_PRP the_AT0 ear_NN1 exam_NN1 ._SENT Phase_NN1 2_CRD included_VVD earset_AJ0 installation_NN1 and_CJC filling_VVG comprised_VVN of_PRF insertion_NN1 of_PRF a_AT0 soft_AJ0 earplug_NN1 and_CJC filling_VVG the_AT0 ear_NN1 canal_NN1 with_PRP otic_AJ0 anesthetic_AJ0 solution_NN1 which_DTQ can_VM0 yield_VVI a_AT0 surprising_AJ0 and_CJC ticklish_AJ0 sensation_NN1 with_PRP FLACC_NN1 evaluated_VVN from_PRP 30_CRD s_ZZ0 prior_AJ0 to_PRP the_AT0 iontophoresis_NN1 earset_NN1 first_ORD touching_PRP the_AT0 child_NN1 's_POS head_NN1 until_PRP 60_CRD s_ZZ0 after_PRP otic_AJ0 anesthetic_AJ0 solution_NN1 filling_NN1 of_PRF the_AT0 external_AJ0 ear_NN1 canal_NN1 was_VBD complete_AJ0 ._SENT Phase_NN1 3_CRD consisted_VVD of_PRF iontophoresis_NN1 during_PRP which_DTQ electrical_AJ0 current_NN1 is_VBZ delivered_VVN to_PRP the_AT0 ear_NN1 in_PRP the_AT0 presence_NN1 of_PRF the_AT0 anesthetic_AJ0 solution_NN1 to_TO0 numb_VVI the_AT0 ear_NN1 drum_NN1 with_PRP FLACC_NN1 evaluated_VVN from_PRP the_AT0 initiation_NN1 of_PRF the_AT0 iontophoresis_NN1 process_NN1 until_PRP 60_CRD s_ZZ0 after_PRP the_AT0 otic_AJ0 anesthetic_AJ0 solution_NN1 was_VBD removed_VVN from_PRP the_AT0 external_AJ0 ear_NN1 canal_NN1 ._SENT Phase_NN1 4_CRD included_VVD tympanic_AJ0 membrane_NN1 anesthesia_NN1 assessment_NN1 ,_PUN in_PRP which_DTQ the_AT0 ear_NN1 drum_NN1 is_VBZ lightly_AV0 touched_VVN with_PRP a_AT0 dull_AJ0 otologic_AJ0 instrument_NN1 to_TO0 determine_VVI if_CJS the_AT0 TM_NP0 is_VBZ insensate_AJ0 or_CJC not_XX0 ,_PUN and_CJC tube_NN1 placement_NN1 during_PRP which_DTQ a_AT0 myringotomy_NN1 incision_NN1 is_VBZ made_VVN and_CJC the_AT0 tube_NN1 placed_VVN across_PRP the_AT0 ear_NN1 drum_NN1 ._SENT Phase_NN1 4_CRD FLACC_NN1 evaluation_NN1 was_VBD initiated_VVN from_PRP the_AT0 moment_NN1 the_AT0 speculum_NN1 enters_VVZ the_AT0 ear_NN1 until_PRP 60_CRD s_ZZ0 after_PRP the_AT0 automated_AJ0 tympanostomy_NN1 device_NN1 is_VBZ withdrawn_VVN from_PRP the_AT0 external_AJ0 ear_NN1 canal_NN1 ._SENT Phase_NN1 5_CRD consisted_VVD of_PRF the_AT0 3-min_AJ0 period_NN1 post-procedure_NN1 ,_PUN from_PRP the_AT0 end_NN1 of_PRF the_AT0 prior_AJ0 phase_NN1 until_PRP 180_CRD s_ZZ0 later_AV0 ._SENT In_PRP addition_NN1 ,_PUN a_AT0 sixth_ORD FLACC_NN1 score_NN1 was_VBD assigned_VVN as_PRP an_AT0 overall_AJ0 score_NN1 for_PRP the_AT0 entire_AJ0 procedure_NN1 ._SENT A_AT0 mean_AJ0 FLACC_NN1 score_NN1 for_PRP each_DT0 procedural_AJ0 phase_NN1 and_CJC overall_NN1 was_VBD calculated_VVN from_PRP the_AT0 average_AJ0 FLACC_AJ0 scores_NN2 of_PRF the_AT0 study_NN1 participant_NN1 population_NN1 ._SENT 
Results_NN2 
Most_DT0 patients_NN2 (_PUL 91.4_CRD %_NN0 ,_PUN 203_CRD /_PUN 222_CRD )_PUR were_VBD medically_AV0 indicated_VVN to_TO0 receive_VVI bilateral_AJ0 tubes_NN2 ,_PUN and_CJC tubes_NN2 were_VBD successfully_AV0 placed_VVN in_PRP the_AT0 majority_NN1 of_PRF the_AT0 sample_NN1 ._SENT Successful_AJ0 tube_NN1 placement_NN1 was_VBD achieved_VVN for_PRP 86_CRD %_NN0 (_PUL 175_CRD /_PUN 203_CRD )_PUR of_PRF bilaterally_AV0 indicated_VVN participants_NN2 ,_PUN and_CJC 100_CRD %_NN0 (_PUL 19_CRD /_PUN 19_CRD )_PUR unilateral_AJ0 patients_NN2 (_PUL Lustig_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD )_PUR ._SENT As_CJS per_PRP the_AT0 FDA-agreed_NN1 upon_PRP protocol_NN1 ,_PUN patients_NN2 were_VBD excluded_VVN from_PRP FPS-R_NN1 or_CJC FLACC_NN1 analyses_NN2 if_CJS they_PNP did_VDD not_XX0 successfully_AV0 complete_VVI the_AT0 procedure_NN1 for_PRP all_DT0 indicated_AJ0 ears_NN2 ._SENT Reasons_NN2 for_PRP incomplete_AJ0 procedures_NN2 included_VVD excessive_AJ0 movement_NN1 or_CJC other_AJ0 behavior_NN1 that_CJT interfered_VVD with_PRP completion_NN1 (_PUL n_ZZ0 =_NN1 11_CRD )_PUR ,_PUN inadequate_AJ0 anesthesia_NN1 as_CJS determined_VVN by_PRP the_AT0 tympanic_AJ0 membrane_NN1 anesthesia_NN1 assessment_NN1 (_PUL n_ZZ0 =_NN1 7_CRD )_PUR ,_PUN discomfort_NN1 /_PUN anxiety_NN1 (_PUL n_ZZ0 =_NN1 4_CRD )_PUR ,_PUN anatomic_AJ0 challenges_NN2 (_PUL n_ZZ0 =_NN1 3_CRD )_PUR ,_PUN intolerance_NN1 of_PRF iontophoresis_NN1 (_PUL n_ZZ0 =_NN1 2_CRD )_PUR ,_PUN and_CJC partial_AJ0 tube_NN1 medialization_NN1 (_PUL n_ZZ0 =_NN1 1_CRD )_PUR ._SENT The_AT0 following_AJ0 results_NN2 reflect_VVB the_AT0 194_CRD children_NN2 with_PRP successful_AJ0 tube_NN1 placements_NN2 ._SENT Per_PRP protocol_NN1 and_CJC so_AV0 that_DT0 reports_NN2 reflected_VVD the_AT0 entire_AJ0 procedure_NN1 ,_PUN no_AT0 FPS-R_NN1 scores_NN2 were_VBD collected_VVN from_PRP the_AT0 11_CRD children_NN2 for_PRP whom_PNQ tube_NN1 placement_NN1 was_VBD incomplete_AJ0 ._SENT Similarly_AV0 ,_PUN FLACC_AJ0 analyses_NN2 included_VVD only_AJ0 patients_NN2 with_PRP successful_AJ0 procedures_NN2 given_VVN that_CJT unsuccessful_AJ0 procedures_NN2 would_VM0 be_VBI dissimilar_AJ0 (_PUL e.g._AV0 ,_PUN truncated_AJ0 intervention_NN1 ,_PUN shortened_AJ0 procedure_NN1 )_PUR ._SENT Post_NN1 hoc_NN1 analyses_NN2 revealed_VVD no_AT0 differences_NN2 in_PRP FLACC_AJ0 scores_NN2 between_PRP these_DT0 194_CRD successful_AJ0 cases_NN2 and_CJC the_AT0 full_AJ0 sample_NN1 ._SENT FPS-R_NN1 scores_NN2 are_VBB reported_VVN from_PRP 5-_NN1 to_PRP 12-year-old_AJ0 patients_NN2 except_PRP two_CRD children_NN2 that_CJT were_VBD incapable_AJ0 of_PRF self-reporting_AJ0 FPS-R_NN1 scores_NN2 ;_PUN one_CRD child_NN1 had_VHD autism_NN1 ,_PUN one_PNI had_VHD spinal_AJ0 muscular_AJ0 atrophy_NN1 ._SENT 
FPS-R_NN1 scores_NN2 ranged_VVN from_PRP 0_CRD –_PUN 10_CRD for_PRP all_DT0 phases_NN2 ,_PUN and_CJC FPS-R_NP0 baseline_NN1 pain_NN1 score_NN1 mean_NN1 was_VBD 0.59_CRD (_PUL n_ZZ0 =_NP0 88_CRD ,_PUN SD_NP0 =_NP0 1.46_CRD )_PUR ,_PUN post-tube_AJ0 placement_NN1 mean_AJ0 score_NN1 was_VBD 3.30_CRD (_PUL n_ZZ0 =_NP0 89_CRD ,_PUN SD_NP0 =_NP0 3.39_CRD )_PUR ,_PUN and_CJC 5-min_AJ0 post-procedure_AJ0 mean_AJ0 score_NN1 was_VBD 1.69_CRD (_PUL n_ZZ0 =_NP0 89_CRD ,_PUN SD_NP0 =_NP0 2.43_CRD )_PUR (_PUL Table_NN1 1_CRD )_PUR ._SENT There_EX0 were_VBD no_AT0 significant_AJ0 differences_NN2 in_PRP males_NN2 '_POS and_CJC females_NN2 '_POS tube_NN1 placement_NN1 scores_NN2 ,_PUN p_ZZ0 >_NP0 0.05_CRD ._SENT In_PRP addition_NN1 ,_PUN age_NN1 was_VBD not_XX0 correlated_VVN with_PRP tube_NN1 placement_NN1 FPS-R_NN1 score_NN1 ,_PUN p_ZZ0 >_NP0 0.05_CRD (_PUL Fig._NN1 1_CRD )_PUR ._SENT 
FLACC_NP0 was_VBD scored_VVN for_PRP all_DT0 patients_NN2 except_PRP 5_CRD due_AJ0 to_PRP technical_AJ0 issues_NN2 resulting_VVG in_PRP no_AT0 video_NN1 recording_NN1 ._SENT FLACC_AJ0 scores_NN2 ranged_VVN from_PRP 0_CRD –_PUN 10_CRD for_PRP all_DT0 phases_NN2 except_CJS the_AT0 pre-procedure_AJ0 otoscopy_NN1 ,_PUN which_DTQ ranged_VVD from_PRP 0_CRD –_PUN 8._CRD Across_PRP all_DT0 5_CRD procedural_AJ0 phases_NN2 and_CJC the_AT0 overall_AJ0 impression_NN1 ,_PUN the_AT0 average_AJ0 FLACC_AJ0 behavioral_AJ0 distress_NN1 score_NN1 ranged_VVD from_PRP 0.1_CRD to_PRP 4.0_CRD (_PUL Table_NN1 2_CRD )_PUR ._SENT FLACC_AJ0 pre-procedure_AJ0 otoscopy_NN1 mean_VVB score_NN1 for_PRP all_DT0 subjects_NN2 was_VBD 0.4_CRD (_PUL n_ZZ0 =_NP0 179_CRD ,_PUN SD_NP0 =_NP0 1.5_CRD )_PUR ,_PUN earset_NP0 install_VVB and_CJC filling_VVG mean_AJ0 score_NN1 was_VBD 0.8_CRD (_PUL n_ZZ0 =_NP0 187_CRD ,_PUN SD_NP0 =_NP0 2.2_CRD )_PUR ,_PUN iontophoresis_NN1 mean_AJ0 score_NN1 was_VBD 0.5_CRD (_PUL n_ZZ0 =_NP0 188_CRD ,_PUN SD_NP0 =_NP0 1.6_CRD )_PUR ,_PUN TM_NP0 tap_NN1 and_CJC tube_NN1 placement_NN1 mean_AJ0 score_NN1 was_VBD 2.4_CRD (_PUL n_ZZ0 =_NP0 188_CRD ,_PUN SD_NP0 =_NP0 3.3_CRD )_PUR ,_PUN post-procedure_AJ0 mean_AJ0 score_NN1 was_VBD 0.8_CRD (_PUL n_ZZ0 =_NP0 188_CRD ,_PUN SD_NP0 =_NP0 1.7_CRD )_PUR ,_PUN and_CJC overall_AJ0 procedure_NN1 mean_AJ0 score_NN1 was_VBD 1.3_CRD (_PUL n_ZZ0 =_NP0 189_CRD ,_PUN SD_NP0 =_NP0 2.6_CRD )_PUR ._SENT Breakdown_NN1 of_PRF FLACC_AJ0 scores_NN2 for_PRP each_DT0 age_NN1 group_NN1 is_VBZ further_AV0 described_VVN in_PRP Table_NN1 2._CRD Given_VVN the_AT0 overall_AJ0 low_AJ0 phase_NN1 scores_NN2 ,_PUN statistical_AJ0 analyses_NN2 were_VBD only_AV0 conducted_VVN for_PRP the_AT0 tube_NN1 placement_NN1 phase_NN1 which_DTQ exhibited_VVD the_AT0 highest_AJS FLACC_NN1 scores_NN2 ._SENT There_EX0 were_VBD no_AT0 significant_AJ0 differences_NN2 in_PRP tube_NN1 placement_NN1 FLACC_NN1 scores_NN2 between_PRP boys_NN2 (_PUL n_XX0 =_NP0 110_CRD ,_PUN M_CRD =_NP0 2.14_CRD ,_PUN SD_NP0 =_NP0 3.16_CRD )_PUR and_CJC girls_NN2 (_PUL n_XX0 =_NP0 78_CRD ,_PUN M_CRD =_NP0 2.71_CRD ,_PUN SD_NP0 =_NP0 3.48_CRD )_PUR ,_PUN p_ZZ0 >_NP0 0.05_CRD ._SENT There_EX0 was_VBD a_AT0 significant_AJ0 correlation_NN1 between_PRP FLACC_NN1 and_CJC age_NN1 for_PRP the_AT0 tube_NN1 placement_NN1 phase_NN1 ,_PUN p_ZZ0 <_NP0 0.01_CRD ,_PUN with_PRP younger_AJC participants_NN2 having_VHG higher_AJC FLACC_NN1 scores_NN2 than_CJS older_AJC participants_NN2 (_PUL Fig._NN1 2_CRD )_PUR ._SENT 
Given_VVN the_AT0 differences_NN2 regarding_PRP the_AT0 timing_NN1 of_PRF data_NN0 collection_NN1 for_PRP FPS-R_NN1 and_CJC FLACC_NN1 scores_NN2 ,_PUN comparison_NN1 of_PRF FPS-R_NN1 and_CJC FLACC_NN1 scores_NN2 could_VM0 only_AV0 be_VBI assessed_VVN for_PRP the_AT0 tube_NN1 placement_NN1 phase_NN1 ._SENT At_PRP tube_NN1 placement_NN1 ,_PUN there_EX0 was_VBD not_XX0 a_AT0 significant_AJ0 correlation_NN1 between_PRP FPS-R_NN1 and_CJC FLACC_NN1 scores_NN2 ,_PUN p_ZZ0 >_NP0 0.05_CRD ,_PUN for_PRP children_NN2 ages_NN2 5_CRD –_PUN 12._CRD 
Discussion_NN1 
Results_NN2 were_VBD generally_AV0 consistent_AJ0 with_PRP expectations_NN2 ._SENT Although_CJS there_EX0 were_VBD no_AT0 gender_NN1 differences_NN2 ,_PUN older_AJC children_NN2 displayed_VVD lower_AJC behavioral_AJ0 distress_NN1 ._SENT In_PRP terms_NN2 of_PRF primary_AJ0 aims_NN2 ,_PUN distress_NN1 was_VBD overall_AV0 low_AJ0 as_CJS hypothesized_VVN ,_PUN but_CJC there_EX0 was_VBD variability_NN1 in_PRP outcomes_NN2 ._SENT For_PRP example_NN1 ,_PUN children_NN2 under_PRP 12_CRD months_NN2 old_AJ0 had_VHD relatively_AV0 higher_AJC distress_NN1 ,_PUN especially_AV0 at_PRP the_AT0 tube_NN1 deployment_NN1 phase_NN1 ._SENT This_DT0 was_VBD expected_VVN given_VVN that_CJT we_PNP were_VBD requiring_VVG that_CJT these_DT0 infants_NN2 stay_VVB in_PRP an_AT0 unfamiliar_AJ0 environment_NN1 (_PUL e.g._AV0 ,_PUN relatively_AV0 cold_AJ0 room_NN1 ,_PUN bright_AJ0 lights_NN2 )_PUR ,_PUN remain_VVB supine_AJ0 for_PRP extended_AJ0 periods_NN2 of_PRF time_NN1 ,_PUN and_CJC healthcare_NN1 professionals_NN2 were_VBD touching_VVG and_CJC looking_VVG in_PRP the_AT0 child_NN1 's_POS sensitive_AJ0 ears_NN2 ._SENT In_PRP addition_NN1 ,_PUN at_PRP tube_NN1 deployment_NN1 there_EX0 is_VBZ a_AT0 loud_AJ0 clicking_AJ0 sound_NN1 that_CJT can_VM0 be_VBI startling_AJ0 and_CJC frightening_AJ0 ;_PUN this_DT0 auditory_AJ0 event_NN1 alone_AV0 could_VM0 explain_VVI elevated_AJ0 distress_NN1 behavior_NN1 ._SENT Anecdotal_AJ0 reports_NN2 from_PRP the_AT0 coders_NN2 corroborated_VVD the_AT0 impressions_NN2 that_DT0 distress_NN1 in_PRP young_AJ0 patients_NN2 was_VBD related_VVN to_PRP these_DT0 environmental_AJ0 factors_NN2 rather_AV0 than_CJS the_AT0 myringotomy_NN1 and_CJC tube_NN1 deployment_NN1 procedure_NN1 ._SENT 
As_CJS expected_VVN ,_PUN older_AJC children_NN2 had_VHD minimal_AJ0 to_PRP any_DT0 reported_AJ0 pain_NN1 and_CJC displayed_VVD little_DT0 distress_NN1 ._SENT Specifically_AV0 ,_PUN the_AT0 self-reported_AJ0 pain_NN1 score_NN1 means_NN0 fell_VVD in_PRP the_AT0 "_PUQ mild_AJ0 "_PUQ pain_NN1 range_NN1 based_VVN on_PRP research_NN1 aiming_VVG to_TO0 contextualize_VVI 0_CRD –_PUN 10_CRD pain_NN1 scores_NN2 (_PUL e.g._AV0 ,_PUN Tsze_NP0 et_NP0 al._NP0 ,_PUN 2018_CRD )_PUR ._SENT Acknowledging_VVG important_AJ0 differences_NN2 based_VVN on_PRP setting_NN1 ,_PUN population_NN1 ,_PUN and_CJC procedure_NN1 ,_PUN the_AT0 FPS-R_NN1 pain_NN1 scores_NN2 collected_VVN in_PRP this_DT0 study_NN1 do_VDB not_XX0 appear_VVI to_TO0 be_VBI clinically_AV0 meaningfully_AV0 different_AJ0 than_CJS mean_AJ0 scores_NN2 reported_VVN from_PRP similarly_AV0 aged_PRP patients_NN2 following_VVG surgery_NN1 (_PUL 2.93_CRD ;_PUN von_NP0 Baeyer_NP0 et_NP0 al._NP0 ,_PUN 2009_CRD )_PUR ,_PUN receiving_VVG immunizations_NN2 (_PUL range_NN1 3.0_CRD –_PUN 6.6_CRD ;_PUN Berberich_NP0 &_NP0 Landman_NP0 ,_PUN 2009_CRD ;_PUN Boivin_NP0 et_NP0 al._NP0 ,_PUN 2008_CRD )_PUR ,_PUN dental_AJ0 injections_NN2 (_PUL range_NN1 3.0_CRD –_PUN 6.3_CRD ;_PUN Asvanund_NP0 et_NP0 al._NP0 ,_PUN 2015_CRD ;_PUN Deepak_NP0 et_NP0 al._NP0 ,_PUN 2017_CRD ;_PUN Kamath_NP0 ,_PUN 2013_CRD )_PUR ,_PUN IV_CRD cannulation_NN1 (_PUL 3.9_CRD ;_PUN Taddio_NP0 et_NP0 al._NP0 ,_PUN 2005_CRD )_PUR ,_PUN venipuncture_NN1 (_PUL range_NN1 3.3_CRD –_PUN 6.5_CRD ;_PUN Inal_NP0 &_NP0 Kelleci_NP0 ,_PUN 2012_CRD ;_PUN Karakaya_NP0 &_NP0 Gozen_NP0 ,_PUN 2016_CRD )_PUR ,_PUN and_CJC ear_NN1 piercing_AJ0 (_PUL 3.9_CRD ;_PUN Hicks_NP0 et_NP0 al._NP0 ,_PUN 2001_CRD )_PUR ._SENT The_AT0 mean_AJ0 FPS-R_NN1 score_NN1 reported_VVD five_CRD minutes_NN2 after_PRP tube_NN1 placement_NN1 was_VBD 1.69_CRD ,_PUN suggesting_VVG that_CJT distress_NN1 was_VBD transient_AJ0 ._SENT 
Overall_AV0 ,_PUN the_AT0 mean_AJ0 FLACC_NN1 scores_NN2 in_PRP this_DT0 young_AJ0 sample_NN1 were_VBD generally_AV0 in_PRP a_AT0 range_NN1 that_CJT was_VBD comparable_AJ0 to_TO0 mean_VVI FLACC_AJ0 scores_NN2 reported_VVN for_PRP 4-_NN1 to_PRP 6-year-olds_NN2 receiving_VVG immunization_NN1 injections_NN2 (_PUL Berberich_NP0 &_NP0 Landman_NP0 ,_PUN 2009_CRD ;_PUN Franck_NP0 et_NP0 al._NP0 ,_PUN 2015_CRD )_PUR ,_PUN 4-_AJ0 to_PRP 13-year-olds_NN2 receiving_VVG dental_AJ0 injections_NN2 (_PUL Asvanund_NP0 et_NP0 al._NP0 ,_PUN 2015_CRD ;_PUN Pala_NP0 et_NP0 al._NP0 ,_PUN 2016_CRD ;_PUN Thoppe-Dhamadharan_NP0 et_NP0 al._NP0 ,_PUN 2015_CRD )_PUR ,_PUN 1-_AJ0 to_PRP 10-year-olds_NN2 undergoing_VVG venipuncture_NN1 (_PUL Gupta_NP0 et_NP0 al._NP0 ,_PUN 2014_CRD ;_PUN Minute_NN1 et_NP0 al._NP0 ,_PUN 2012_CRD )_PUR ,_PUN and_CJC 2-_AJ0 to_PRP 7-year-olds_NN2 undergoing_VVG allergy_NN1 skin_NN1 prick_NN1 test_NN1 (_PUL Goldberg_NP0 et_NP0 al._NP0 ,_PUN 2014_CRD )_PUR ._SENT A_AT0 review_NN1 of_PRF the_AT0 literature_NN1 indicates_VVZ that_CJT younger_AJC children_NN2 generally_AV0 display_VVB higher_AJC behavioral_AJ0 distress_NN1 than_CJS older_AJC children_NN2 ,_PUN consistent_AJ0 with_PRP the_AT0 findings_NN2 in_PRP this_DT0 study_NN1 (_PUL von_NP0 Baeyer_NP0 &_NP0 Spagrud_NP0 ,_PUN 2007_CRD ;_PUN Young_NP0 ,_PUN 2005_CRD )_PUR ._SENT 
The_AT0 in-office_AJ0 tympanostomy_NN1 procedure_NN1 FLACC_NN1 can_VM0 be_VBI compared_VVN to_PRP post-operative_AJ0 distress_NN1 after_PRP OR-placed_AJ0 tympanostomy_NN1 tubes_NN2 ._SENT Mean_VVB FLACC_AJ0 scores_NN2 in_PRP the_AT0 recovery_NN1 room_NN1 after_PRP OR-placed_AJ0 tympanostomy_NN1 tubes_NN2 from_PRP two_CRD separate_AJ0 studies_NN2 ranged_VVN from_PRP 2.0_CRD to_PRP 4.8_CRD ,_PUN varying_VVG with_PRP use_NN1 of_PRF pre-operative_AJ0 and_CJC intra-operative_AJ0 medications_NN2 such_DT0 as_PRP midazolam_NN1 ,_PUN dexmedetomidine_NN1 ,_PUN acetaminophen_NN1 ,_PUN fentanyl_NN1 ,_PUN and_CJC morphine_NN1 (_PUL Hippard_NP0 et_NP0 al._NP0 ,_PUN 2012_CRD ;_PUN Dewhirst_NP0 et_NP0 al._NP0 ,_PUN 2014_CRD )_PUR ._SENT In_PRP a_AT0 large_AJ0 study_NN1 of_PRF 3669_CRD children_NN2 ,_PUN 21_CRD %_NN0 of_PRF patients_NN2 in_PRP the_AT0 recovery_NN1 after_PRP OR-placed_AJ0 tubes_NN2 had_VHD FLACC_AJ0 scores_NN2 of_PRF 7_CRD –_PUN 10_CRD ,_PUN despite_PRP pre-operative_AJ0 midazolam_NN1 and_CJC intra-operative_AJ0 fentanyl_NN1 or_CJC ketorolac_NN1 (_PUL Stricker_NP0 et_NP0 al._NP0 ,_PUN 2017_CRD )_PUR ._SENT It_PNP is_VBZ not_XX0 known_VVN if_CJS this_DT0 post-operative_AJ0 distress_NN1 is_VBZ due_AJ0 to_PRP excessive_AJ0 pain_NN1 from_PRP the_AT0 tube_NN1 placement_NN1 or_CJC related_VVN to_PRP the_AT0 after-effects_NN2 of_PRF the_AT0 anesthetic_AJ0 (_PUL i.e._AV0 ,_PUN emergence_NN1 agitation_NN1 )_PUR ._SENT In_PRP contrast_NN1 ,_PUN this_DT0 office_NN1 tube_NN1 placement_NN1 study_NN1 using_VVG local_AJ0 anesthesia_NN1 had_VHD low_AJ0 mean_AJ0 FLACC_NN1 scores_NN2 3-min_NN1 post-procedure_NN1 consistent_AJ0 with_PRP low_AJ0 post-operative_AJ0 distress_NN1 ._SENT 
The_AT0 lack_NN1 of_PRF correlation_NN1 between_PRP FPS-R_NP0 and_CJC FLACC_NP0 scores_NN2 is_VBZ notable_AJ0 ._SENT Data_NN0 within_PRP a_AT0 single_AJ0 study_NN1 and_CJC across_PRP studies_NN2 suggest_VVB that_CJT associations_NN2 between_PRP FPS-R_NP0 and_CJC FLACC_NP0 range_NN1 from_PRP no_AT0 significant_AJ0 relationship_NN1 to_PRP strong_AJ0 correlations_NN2 (_PUL da_NP0 Silva_NP0 et_NP0 al._NP0 ,_PUN 2011_CRD ;_PUN Emmott_NP0 et_NP0 al._NP0 ,_PUN 2017_CRD )_PUR ._SENT Consistent_AJ0 with_PRP the_AT0 perspective_NN1 that_CJT self-report_AJ0 and_CJC observer-report_AJ0 scales_NN2 might_VM0 be_VBI reflecting_VVG different_AJ0 —_PUN and_CJC valuable_AJ0 —_PUN aspects_NN2 of_PRF the_AT0 same_DT0 event_NN1 (_PUL Cohen_NP0 et_NP0 al._NP0 ,_PUN 2008_CRD )_PUR ,_PUN our_DPS findings_NN2 underscore_VVB that_CJT we_PNP assessed_VVD different_AJ0 outcomes_NN2 in_PRP line_NN1 with_PRP the_AT0 long-standing_AJ0 recommendation_NN1 that_CJT pediatric_AJ0 procedural_AJ0 pain_NN1 assessment_NN1 be_VBI conducted_VVN in_PRP a_AT0 multimethod_AJ0 manner_NN1 (_PUL American_AJ0 Academy_NN1 of_PRF Pediatrics_NN1 Committee_NN1 on_PRP Psychosocial_AJ0 Aspects_NN2 of_PRF Child_NN1 and_CJC Family_NN1 Health_NN1 ;_PUN Task_NN1 Force_NN1 on_PRP Pain_NN1 in_PRP Infants_NN2 ,_PUN Children_NN2 and_CJC Adolescents_NN2 ;_PUN 2001_CRD ;_PUN Cohen_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD ;_PUN McGrath_NP0 &_NP0 Gillespie_NP0 ,_PUN 2001_CRD )_PUR ._SENT 
It_PNP is_VBZ important_AJ0 to_TO0 note_VVI that_CJT whereas_CJS the_AT0 majority_NN1 of_PRF children_NN2 reported_VVN and_CJC displayed_VVN minimal_AJ0 distress_NN1 ,_PUN a_AT0 subset_NN1 of_PRF patients_NN2 reported_VVN or_CJC exhibited_VVN high_AJ0 distress_NN1 ._SENT This_DT0 distress_NN1 was_VBD transitory_AJ0 as_CJS shown_VVN by_PRP low_AJ0 scores_NN2 within_PRP 3-min_AJ0 post-procedure_NN1 ;_PUN peaked_VVN during_PRP tube_NN1 delivery_NN1 ;_PUN and_CJC while_CJS discomfort_NN1 may_VM0 have_VHI been_VBN associated_VVN with_PRP tube_NN1 insertion_NN1 ,_PUN anecdotally_AV0 the_AT0 distress_NN1 often_AV0 occurred_VVN when_CJS a_AT0 child_NN1 was_VBD encouraged_VVN to_TO0 lay_VVI in_PRP a_AT0 supine_AJ0 position_NN1 ,_PUN when_CJS the_AT0 head_NN1 was_VBD stabilized_VVN ,_PUN or_CJC when_CJS the_AT0 click_NN1 of_PRF the_AT0 device_NN1 surprised_VVD the_AT0 child_NN1 ._SENT The_AT0 broader_AJC pediatric_AJ0 procedural_AJ0 literature_NN1 indicates_VVZ that_CJT children_NN2 exhibit_VVB higher_AJC distress_NN1 when_CJS laying_VVG on_PRP their_DPS back_NN1 during_PRP medical_AJ0 procedures_NN2 (_PUL Bice_NP0 &_NP0 Wyatt_NP0 ,_PUN 2017_CRD ;_PUN Cohen_NP0 ,_PUN 2008_CRD ;_PUN Sri_NP0 Rahyanti_NP0 et_NP0 al._NP0 ,_PUN 2017_CRD )_PUR ._SENT 
Particularly_AV0 in_PRP pediatric_AJ0 patients_NN2 ,_PUN variability_NN1 in_PRP pain_NN1 and_CJC distress_NN1 is_VBZ anticipated_VVN ._SENT This_DT0 is_VBZ believed_VVN to_TO0 be_VBI due_AJ0 ,_PUN in_PRP part_NN1 ,_PUN to_PRP the_AT0 fact_NN1 that_CJT children_NN2 have_VHB challenges_NN2 in_PRP distinguishing_AJ0 pain_NN1 from_PRP emotional_AJ0 aspects_NN2 of_PRF distress_NN1 ._SENT FLACC_AJ0 scores_NN2 have_VHB been_VBN shown_VVN to_PRP range_NN1 from_PRP 0_CRD to_PRP 10_CRD ,_PUN associated_VVN with_PRP simple_AJ0 palpation_NN1 of_PRF a_AT0 vein_NN1 in_PRP children_NN2 1-_AJ0 to_PRP 6-year-olds_NN2 (_PUL Lunoe_NP0 et_NP0 al._NP0 ,_PUN 2015_CRD )_PUR ,_PUN and_CJC Koc_NP0 and_CJC Gozen_NP0 (_PUL 2015_CRD )_PUR showed_VVD that_CJT 83_CRD %_NN0 of_PRF FLACC_AJ0 scores_NN2 for_PRP infants_NN2 (_PUL 1_CRD to_PRP 12_CRD months_NN2 old_AJ0 )_PUR were_VBD greater_AJC than_CJS 4_CRD after_PRP simple_AJ0 physical_AJ0 measurements_NN2 (_PUL height_NN1 ,_PUN weight_NN1 ,_PUN head_NN1 circumference_NN1 ,_PUN and_CJC oxygen_NN1 saturation_NN1 )_PUR ._SENT Tsze_NP0 et_NP0 al._NP0 (_PUL 2018_CRD )_PUR demonstrated_VVD that_CJT 32_CRD %_NN0 of_PRF children_NN2 (_PUL mean_VVB age_NN1 of_PRF 8.6_CRD years_NN2 old_AJ0 )_PUR who_PNQ were_VBD not_XX0 in_PRP any_DT0 pain_NN1 reported_VVD an_AT0 FPS-R_AJ0 score_NN1 of_PRF 2_CRD and_CJC over_PRP 11_CRD %_NN0 of_PRF children_NN2 who_PNQ were_VBD not_XX0 in_PRP any_DT0 pain_NN1 reported_VVD FPS-R_AJ0 scores_NN2 of_PRF 4_CRD ,_PUN 6_CRD ,_PUN 8_CRD or_CJC 10._CRD These_DT0 reports_NN2 suggest_VVB that_CJT FLACC_NP0 and_CJC FPS-R_NP0 evaluation_NN1 cannot_NN1 distinguish_VVB between_PRP pain_NN1 and_CJC the_AT0 emotional_AJ0 aspects_NN2 of_PRF distress_NN1 ,_PUN as_CJS noted_VVN by_PRP Blount_NP0 and_CJC Loiselle_NP0 (_PUL 2009_CRD )_PUR ._SENT 
We_PNP wish_VVB to_TO0 highlight_VVI limitations_NN2 and_CJC future_AJ0 directions_NN2 ._SENT First_ORD ,_PUN the_AT0 lack_NN1 of_PRF a_AT0 control_NN1 condition_NN1 prohibits_VVZ attributions_NN2 of_PRF low_AJ0 distress_NN1 to_PRP qualities_NN2 of_PRF the_AT0 device_NN1 or_CJC behavioral_AJ0 program_NN1 ._SENT However_AV0 ,_PUN given_VVN the_AT0 sensitivity_NN1 of_PRF the_AT0 eardrum_NN1 ,_PUN it_PNP is_VBZ challenging_AJ0 if_CJS not_XX0 unethical_AJ0 to_TO0 conduct_VVI tympanostomy_NN1 absent_AJ0 anesthesia_NN1 and_CJC behavioral_AJ0 support_NN1 for_PRP pediatric_AJ0 patients_NN2 ._SENT However_AV0 ,_PUN dismantling_VVG studies_NN2 might_VM0 help_VVI identify_VVI key_AJ0 intervention_NN1 ingredients_NN2 ._SENT Second_ORD ,_PUN generalizability_NN1 of_PRF findings_NN2 is_VBZ limited_AJ0 given_VVN our_DPS inclusion_NN1 and_CJC exclusion_NN1 criteria_NN2 which_DTQ restricted_VVD the_AT0 patient_AJ0 population_NN1 to_PRP children_NN2 with_PRP anatomy_NN1 compatible_AJ0 with_PRP safe_AJ0 use_NN1 of_PRF the_AT0 devices_NN2 and_CJC anesthetic_AJ0 ,_PUN and_CJC with_PRP compliant_AJ0 behavior_NN1 for_PRP the_AT0 office_NN1 procedure_NN1 ._SENT Future_AJ0 research_NN1 might_VM0 evaluate_VVI whether_CJS behavioral_AJ0 strategies_NN2 might_VM0 be_VBI effective_AJ0 for_PRP more_DT0 challenging_AJ0 patients_NN2 ._SENT Third_ORD ,_PUN two_CRD of_PRF the_AT0 authors_NN2 were_VBD funded_VVN for_PRP work_NN1 on_PRP the_AT0 project_NN1 ,_PUN which_DTQ could_VM0 have_VHI introduced_VVN investigator_NN1 bias_NN1 ._SENT That_DT0 said_VVD ,_PUN all_DT0 data_NN0 coding_NN1 was_VBD conducted_VVN by_PRP researchers_NN2 who_PNQ were_VBD blind_AJ0 to_TO0 study_VVI hypotheses_NN2 ._SENT Given_VVN that_CJT the_AT0 behavioral_AJ0 program_NN1 appeared_VVD to_TO0 be_VBI helpful_AJ0 to_PRP some_DT0 but_CJC not_XX0 all_DT0 children_NN2 ,_PUN we_PNP encourage_VVB researchers_NN2 in_PRP this_DT0 area_NN1 to_TO0 assess_VVI additional_AJ0 unique_AJ0 characteristics_NN2 (_PUL e.g._AV0 ,_PUN coping_VVG styles_NN2 ,_PUN temperament_NN1 )_PUR to_TO0 advance_VVI the_AT0 field_NN1 in_PRP matching_AJ0 intervention_NN1 components_NN2 and_CJC strategies_NN2 to_PRP individuals_NN2 ._SENT 
Myringotomy_NN1 with_PRP tympanostomy_NN1 tube_NN1 placement_NN1 is_VBZ the_AT0 most_AV0 common_AJ0 pediatric_AJ0 surgery_NN1 ,_PUN and_CJC it_PNP is_VBZ a_AT0 fairly_AV0 simple_AJ0 and_CJC brief_AJ0 procedure_NN1 ._SENT Unfortunately_AV0 ,_PUN the_AT0 current_AJ0 norm_NN1 is_VBZ to_TO0 use_VVI general_AJ0 anesthesia_NN1 ,_PUN which_DTQ invites_VVZ a_AT0 host_NN1 of_PRF potential_AJ0 behavioral_AJ0 and_CJC other_AJ0 problems_NN2 for_PRP young_AJ0 patients_NN2 (_PUL e.g._AV0 ,_PUN Kain_NN1 et_NP0 al._NP0 ,_PUN 1999_CRD ;_PUN Zhang_NP0 et_NP0 al._NP0 ,_PUN 2015_CRD )_PUR ._SENT The_AT0 current_AJ0 findings_NN2 in_PRP conjunction_NN1 with_PRP Lustig_NP0 et_NP0 al._NP0 (_PUL 2020_CRD )_PUR indicate_VVB that_CJT the_AT0 Tula_AJ0 System_NN1 and_CJC behavioral_AJ0 program_NN1 allow_VVB pediatric_AJ0 patients_NN2 to_TO0 receive_VVI in-office_AJ0 tympanostomy_NN1 tube_NN1 placement_NN1 without_PRP general_AJ0 anesthesia_NN1 ,_PUN without_PRP sedation_NN1 ,_PUN and_CJC without_PRP mechanical_AJ0 restraints_NN2 ,_PUN and_CJC with_PRP minimal_AJ0 distress_NN1 ._SENT 
