Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02189642|
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : March 10, 2017
|Condition or disease|
|Surgical Procedures, Operative|
|Study Type :||Observational|
|Actual Enrollment :||643 participants|
|Official Title:||Evaluation of Perioperative Outcomes in Children: Creation of the Boston Children's Hospital Perioperative Outcomes Registry|
|Study Start Date :||July 13, 2013|
|Actual Primary Completion Date :||March 8, 2017|
|Actual Study Completion Date :||March 8, 2017|
Genito-Urinary/Urology Surgical Procedure Types
Pediatric patients undergoing circumcision, orchidopexy, hypospadias repair, hernia repair, cystoscopy, pyeloplasty, and ureteral reimplants or ureteral stents.
Otolaryngology Surgical Procedure Types
Pediatric patients undergoing tonsil and/or adenoid removal, tympanostomy, tympanoplasty, and mastoidectomy.
Orthopaedics Surgical Procedure Types
Patients undergoing hip and knee arthroscopies, hardware removal, and tendon lengthening.
Plastic Surgery Surgical Procedure Type
Pediatric patients undergoing alveolar cleft repair.
- Incidence of Significant Pain in PACU [ Time Frame: On day of surgery. ]Incidence of significant pain defined by pain behavior information from the Faces-Legs-Activity-Cry-Consolability (FLACC) scale, Wong-Baker Faces scale, visual analog scale/numerical scale or adapted numerical rating scale - equal to or more than 5 on a scale from 0 to 10 at any time during the PACU stay.
- Incidence of Agitation in PACU [ Time Frame: On day of surgery. ]Incidence of agitation using emergence agitation categorization with Pediatric Agitation Emergence Delirium (PAED) scale equal to or more than 10 on this scale for more than 30 seconds during the recovery period.
- Incidence of Post-Operative Nausea or Vomiting [ Time Frame: On day of surgery. ]Post-operative vomiting (POV) will be measured by episodes of vomiting or retching in PACU. This will be a binary outcome - either vomiting/retching occurred or it did not.
- Satisfaction of Patients and Families with Post-Operative Care [ Time Frame: At two days and two weeks after surgery. ]Satisfaction of patients and families with perioperative care, as determined from a three-question satisfaction survey allowing participating families to rate their recovery experience, global surgical experience, and need for further care at another healthcare facility.
- Post-Hospitalization Behavior Changes [ Time Frame: At two days and two weeks after surgery. ]Post-hospitalization behaviors changes defined by development of 4 or more behavior changes on the Post Hospitalization Behavior Questionnaire (PHBQ) or development of increased stress levels on the Child PTSD Symptom Scale (CPSS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189642
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|