Psychological Influences on Postoperative Recovery (NIH)

University of California Irvine (UCI)

Status and phase: Completed; Phase 2

Conditions: Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Adenoidectomy; Pain, Postoperative; Care, Postoperative; Tonsillectomy

Treatments: Behavioral: Parental Presence during Induction of Anesthesia; Other: PPIA preparation program PLUS Midazolam premedication; Behavioral: Preoperative Preparation Program (Child Life Specialist); Drug: Midazolam

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00581139

R01HD037007-01 (U.S. NIH Grant/Contract)

9801009972 [2008-6723]

Details and patient eligibility

About

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.

Enrollment: 241 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient tonsillectomy or tonsils/adenoids
• ASA I, II

Exclusion criteria

• Developmental delay
• ASA III-IV
• Psychotropic medication
• Meds which interfere with metabolism of midazolam
• 36 weeks gestation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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241 participants in 4 patient groups

1

Active Comparator group

Treatment:

Behavioral: Preoperative Preparation Program (Child Life Specialist)

2

Active Comparator group

Treatment:

Drug: Midazolam

3

Active Comparator group

Treatment:

Behavioral: Parental Presence during Induction of Anesthesia

4

Active Comparator group

Treatment:

Other: PPIA preparation program PLUS Midazolam premedication