Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Children with developmental delay are at higher risk for inadequate pain assessment and management. Patient controlled analgesia (PCA) allows patients to administer opioids by pushing a PCA button when needed. This eliminates the delay of waiting for a nurse to obtain and administer pain medication. PCA has been shown to be safe, effective, and superior to intramuscular, intermittent opioid dosing for pain management in children. Often, children with developmental delays cannot operate a PCA independently, can not self report their pain and are often given pain medication "as needed" through an IV. Parent/Nurse Controlled Analgesia (PNCA) allows parents and nurses to push the PCA button for patients who are not able to do so themselves. This way of giving pain medicine has not been thoroughly studied. Some healthcare professionals use PNCA for these children, others do not. This study is being done to compare PNCA & intermittent opioid administration. Participants will be randomized into one of the three study groups:

1. Parent/Nurse controlled Analgesia (PNCA) with a continuous intravenous (IV)infusion of pain medicine.

2. PNCA without continuous IV infusion of pain medicine.

3. Pain medicine given through IV administered on an "as needed" basis(PRN) by the nurse.

The Acute Pain Service will follow all three groups of patients throughout the study. This team specializes in the management of children's pain. Pain team is also available 24 hours a day, 7 days a week. The study will continue until child can tolerate pain medication in his/her stomach.

Data will be collected regarding safety, efficacy, parent & Nurse satisfaction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00743730
Study type Interventional
Source Medical College of Wisconsin
Contact
Status Completed
Phase N/A
Start date June 2005
Completion date February 2010

See also
  Status Clinical Trial Phase
Completed NCT05619796 - Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation N/A
Recruiting NCT05338671 - Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment Phase 4
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Completed NCT05584696 - Effectiveness of Green Color Exposure on Dental Anxiety N/A
Not yet recruiting NCT05255146 - Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery N/A
Not yet recruiting NCT06020196 - The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery N/A
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Completed NCT01681966 - A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery Phase 2
Completed NCT01442818 - Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery N/A
Completed NCT00625911 - Ketamine Improves Post-Thoracotomy Analgesia N/A
Terminated NCT05494125 - Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery N/A
Recruiting NCT04767399 - Comparison of Postoperative Pain After Instrumentation in Different Visits With Different Single File Systems. N/A
Not yet recruiting NCT05863624 - Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia N/A
Completed NCT06048744 - Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy N/A
Active, not recruiting NCT05374499 - Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions Phase 4
Completed NCT06082479 - The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis N/A
Completed NCT05552391 - Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control Phase 4
Completed NCT05510947 - Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty
Completed NCT06065683 - Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours
Recruiting NCT04909060 - Does the Newborn Infant Parasympathetic Evaluation (NIPE) Index Predict Postsurgical Pain in Children