Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

Completed

• Conditions: Surgical Procedures, Operative

• Registration Number: NCT02189642
• Lead Sponsor: Boston Children's Hospital

Brief Summary

The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators hypothesize quality of PACU outcomes will correlate with preoperative demographic and behavioral characteristics as well as intraoperative and anesthetic procedures/techniques. This study will help the investigators improve post anesthetic care quality and create a higher level of satisfaction for patients, family, and health care providers.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-13
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Status Verified: 2017-03
• Primary Completion: 2017-03-08
• Study Completion: 2017-03-08
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 643

Inclusion Criteria

• All patients scheduled for surgery at Boston Children's Hospital ages 6 months to 30 years undergoing the following qualifying surgeries:

Genito-Urinary/Urology Department:

• Circumcision, Orchidopexy, Hypospadias Repair, Hernia Repair, Cystoscopy, Pyeloplasty, and Ureteral Reimplants or Ureteral Stents.

Otolaryngology Department:

• Tonsil and/or Adenoid Removal, Tympanostomy, Tympanoplasty, and Mastoidectomy.

Orthopaedics Department:

• Hip and Knee Arthroscopies, Hardware Removal, and Tendon Lengthening.
• Plastic Surgery Department: Alveolar Cleft Repair.

Exclusion Criteria

• English as a second language.
• < 6 months, > 21 or 30 (hip patients only).
• Resident of a residential facility or ward of state.
• Guardianship status unclear.
• Not headed to the PACU post-operatively.
• Day of: Projected to arrive in PACU after 3 PM.
• Duration of surgery well beyond ordinary for procedure type.
• Exceptionally complex medical history.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Significant Pain in PACU	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction of Patients and Families with Post-Operative Care	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	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).

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States