N/A
Completed N=94
Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay
Post Operative Pain
Source: ClinicalTrials.gov NCT00743730 ↗
Enrolled (actual)
94
Serious AEs
1.1%
Results posted
Nov 2016
Primary outcomePrimary: Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale — 1.0; 1.8; 1.5 units on a scale
Summary
The purpose of this study is to compare, the safety, efficacy and level of parent and nurse satisfaction with three methods of opioid administration post-operatively in children (4-18 years of age) with developmental delay.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale |
1.0; 1.8; 1.5 | — |
| SECONDARY Number of Patients Requiring Naloxone for Respiratory Depression |
1; 0; 0 | — |
| SECONDARY Parent Satisfaction With the Administration Technique |
1.32; 1.48; 1.65 | — |
Eligibility Criteria
Inclusion Criteria
- Children with developmental delay between 4 and 18 years of age who are unable to operate PCA due to developmental delay.
- Children scheduled for surgery anticipated to require >24hour stay with anticipation of IV narcotics will be required.
- Children whose parents are able to verbalize an understanding of PNCA.
- Parents with fluency in english(both speaking and writing).
Exclusion Criteria
- Patients who do not meet inclusion criteria
- Patients whose parents do not give informed consent
- patients allergic to both morphine and hydromorphone
- patients with severe physiologically altering obstructive sleep apnea
- Patients who are or are expected to remain on a ventilator
- Patients receiving an epidural -
Data sourced from ClinicalTrials.gov (NCT00743730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.