[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06505148":3,"trial-entities:NCT06505148":93,"trial-summary:NCT06505148":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":53,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":14,"eligibility_criteria":61,"std_ages":70,"locations":73,"central_contacts":89,"overall_officials":90,"references":91,"see_also_links":92},"NCT06505148","024-301","Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?","NOT_YET_RECRUITING","2025-08-01","2024-07","2024-07-22","2024-08-01","Baylor Research Institute","OTHER",false,"To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.","The purpose of the study is to compare the difference in pain control in the pediatric general surgery population of those who receive alternating acetaminophen and ibuprofen every 3 hours to those who receive acetaminophen and ibuprofen combined therapy around the clock. Additionally, to investigate the difference in parent adherence to pain treatment plans between the alternating group from the combined group.",[18],"Pediatric Disorder",[20,21,22,23],"non opioid","pain management","pediatric pain","pediatric pain management","INTERVENTIONAL","TREATMENT",[27],"PHASE4",{"count":29,"type":30},80,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Acetaminophen","administered alternatively with other drug",[37,38],"Group A","Group B",{"type":33,"name":40,"description":35,"armGroupLabels":41},"Ibuprofen",[37,38],[43,47,50],{"measure":44,"description":45,"timeFrame":46},"Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.","Pain will be assessed using an age-appropriate pain rating scale. The FLACC is an interval scale quantifying pain behavior with scores ranging from 0 no pain behaviors to 10 most possible pain behaviors. The five categories of behaviors assessed with the FLAC include facial expressions, leg movement, activity, crying, and consolability.","24, 48, and 72 hours after surgery",{"measure":48,"description":49,"timeFrame":46},"Pain Visual Analog Scale (VAS)","This tool portrays a 10cm ruler visual and the patient selects the marker indicating their pain intensity, 0 indicating no pain to 10 indicating the worst pain possible.",{"measure":51,"description":52,"timeFrame":46},"Numeric Pain Rating Scale (NPRS)","The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain.",[54],{"measure":55,"description":56,"timeFrame":57},"Parent\u002F guardian adherence","Adherence will be assessed by asking the parent\u002Fguardian regarding their ability to follow pain regimen and the ease to follow the instructions.","72 hours after surgery","ALL","3 Years","18 Years",{"inclusion":62,"exclusion":65,"raw_text":69},[63,64],"Age group: 3 years to 18 years","General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)",[66,67,68],"Patients who are allergic to acetaminophen and\u002For ibuprofen","Patients being evaluated by SANE or evaluated for nonaccidental trauma","Patients admitted post-op","Inclusion Criteria:\n\n* Age group: 3 years to 18 years\n* General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)\n\nExclusion Criteria:\n\n* Patients who are allergic to acetaminophen and\u002For ibuprofen\n* Patients being evaluated by SANE or evaluated for nonaccidental trauma\n* Patients admitted post-op\n\nThe study will take place at McLane Children's Hospital Temple Market. Patients who are pregnant.",[71,72],"CHILD","ADULT",[74],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":86},"Baylor Scott & White Health Temple Market","Temple","Texas","76508","United States",[81],{"name":82,"role":83,"phone":84,"email":85},"Marlene T Porter, PhD","CONTACT","254-724-9069","marlene.porter@bswhealth.org",{"lat":87,"lon":88},31.09823,-97.34278,[],[],[],[],{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Pediatric AIDS",[],{"nct_id":4,"found":98,"summary":99,"prompt_version":109},true,{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This interventional study plans to enroll 80 participants. It compares two different ways of giving pain medication.","completed","Pain Control in Pediatric Surgery: Acetaminophen and Ibuprofen","This study is looking at the best way to manage pain for children (ages 3 to 18) after general surgery, such as for hernias or appendectomies. Researchers want to compare two approaches: giving acetaminophen and ibuprofen alternately every 3 hours, versus giving them together at the same time around the clock. The goal is to see which method provides better pain control. Success will be measured by how much pain children report using different pain scales (FLACC, VAS, NPRS) at 24, 48, and 72 hours after surgery. You may be able to join if your child is having general surgery and is not allergic to acetaminophen or ibuprofen. The current recruitment status is unclear.","Pain levels will be measured at 24, 48, and 72 hours after surgery.",114,"Not specified in the trial record.","Not stated in the trial record.",[34,40],"v2"]