CompletedNot Applicable

Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay

United States94 participantsStarted 2005-06

Plain-language 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.

Who can participate

Age range

4 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 -

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale

Timeframe: First 24 hours on study

Trial details

NCT IDNCT00743730

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-02

Results submitted2015-11-04

View on ClinicalTrials.gov More Post Operative Pain trials

Who can participate

Age range

4 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.