Personalizing Perioperative Analgesia in Children

Status Active, not recruiting

Clinical Trial Summary

In the United States alone, each year approximately 5 million children undergo painful surgery, many of them experience serious side-effects with opioids and inadequate pain relief. Safe and effective analgesia is an important unmet critical medical need in children and its continued existence is an important perioperative safety and economic problem. Inadequate pain relief and serious side effects from perioperative opioids occur frequently in up to 50% of children. Morphine, the most commonly used perioperative opioid, has a narrow therapeutic index and large inter-patient variations in analgesic response and serious side effects. Frequent inter-individual variations in responses to morphine have significant clinical and economic impact with inadequate pain relief at one end of the spectrum of responses and serious adverse effects such as respiratory depression at the other end. Much of the inter-individual variability in response to a dose of morphine following surgical procedures can be explained by single nucleotide polymorphisms (SNPs) in a subset of the genes that encode proteins involved in pain mechanisms and opioid pathway.

Clinical Trial Description

Measures and Procedures: Participants will receive standard care, standard anesthetic and an intraoperative dose of morphine per the clinical team. Research procedures will include: 1. Blood draws for genotyping candidate genes and exploratory genes 2. Standardized PACU (post anesthesia care unit) Protocol: Subjective pain assessments: Numerical Rating Scale (NRS) 0 to 10. Objective assessment with FLACC (facial expression; leg movement; activity; cry; and consolability) scale, 0-10. 3. Significant postoperative pain will be managed in the PACU with rescue doses of morphine and opioids by the clinical team. Analgesic interventions and morphine requirements are collected 4. Effects of opioids on pupil measures 5. Respiratory response to 5% carbon dioxide preoperatively and postoperatively (first 350 patients only). Another measure of end tidal carbon dioxide will be implemented when the device is clinically available. 6. Serial blood draws for morphine pharmacokinetic modeling (through subject #351). 7. Opioid adverse effects in PACU and at home. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01140724
Study type	Observational
Source	University of Pittsburgh
Contact
Status	Active, not recruiting
Phase
Start date	February 7, 2022
Completion date	October 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04633850` - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting	`NCT03181620` - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation	N/A
Completed	`NCT04579354` - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia	N/A
Recruiting	`NCT06007378` - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery	N/A
Recruiting	`NCT05943015` - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks	N/A
Completed	`NCT04544228` - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy	N/A
Completed	`NCT03678168` - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries	N/A
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Completed	`NCT03663478` - Continuous TQL Block for Elective Cesarean Section	Phase 4
Completed	`NCT04176822` - Designing Animated Movie for Preoperative Period	N/A
Completed	`NCT05170477` - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment	N/A
Not yet recruiting	`NCT04561856` - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone	Phase 4
Completed	`NCT06425601` - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy	N/A
Completed	`NCT03612947` - TAP Block in Laparoscopic Cholecystectomy.	Phase 2
Completed	`NCT05974501` - Pre vs Post Block in Total Knee Arthroplasty (TKA)	Phase 4
Completed	`NCT05995912` - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain	Phase 2
Completed	`NCT04571515` - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain	Phase 2
Active, not recruiting	`NCT04190355` - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain	N/A
Recruiting	`NCT05145153` - Incidence of Chronic Pain After Thoracic Surgery
Recruiting	`NCT03697278` - Monitoring Postoperative Patient-controlled Analgesia (PCA)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.