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Clinical Trials/NCT02189642
NCT02189642
Completed
Not Applicable

Evaluation of Perioperative Outcomes in Children: Creation of the Boston Children's Hospital Perioperative Outcomes Registry

Boston Children's Hospital1 site in 1 country643 target enrollmentJuly 13, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgical Procedures, Operative
Sponsor
Boston Children's Hospital
Enrollment
643
Locations
1
Primary Endpoint
Incidence of Significant Pain in PACU
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 13, 2013
End Date
March 8, 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph P. Cravero

Department of Anesthesiology, Senior Associate

Boston Children's Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Satisfaction of Patients and Families with Post-Operative Care(At two days and two weeks after surgery.)
  • Post-Hospitalization Behavior Changes(At two days and two weeks after surgery.)

Study Sites (1)

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