Enhanced Pain Education for Post-Surgery Pain in Children

Overseen By Lena S. Sun, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: ASA III, ASA IV, inpatient, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

900 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Enhanced Pain Education for Post-Surgery Pain in Children?

Research indicates that effective pain management, including proactive strategies and parental involvement, can significantly reduce postoperative pain in children. Studies show that when children receive comprehensive pain management, they experience fewer negative effects and better recovery outcomes. ^{1 2 3 4 5}

Is enhanced pain education for post-surgery pain in children safe?

Recent studies suggest that effective pain management strategies, including education, can be safely administered to children undergoing surgery, with minimal negative effects when properly managed. ^{1 2 6 7 8}

How is the treatment for post-surgery pain in children different from other treatments?

The treatment focuses on a comprehensive approach called multimodal pain management, which combines different methods like medications and nerve blocks to prevent and manage pain effectively. This approach is unique because it emphasizes individualized care and involves parents in the process, ensuring that pain management is tailored to each child's needs and monitored closely for effectiveness. ^{1 2 6 9 10}

What is the purpose of this trial?

This study aims to assess the differences in overall pain severity, pain management, and satisfaction during recovery period between two groups of children who either receive or do not receive additional education related to expectation and management of postoperative pain.

Research Team

Lena Sun, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for children aged 1-6 years who are undergoing day surgery and have a low risk of complications (ASA status I or II). It's not suitable for kids with more serious health issues (ASA III or IV), those staying in the hospital overnight, or those with conditions affecting pain sensation.

Inclusion Criteria

I am in good or fair health and will spend less than a day in recovery after surgery before going home.

I am between 1 and 6 years old and scheduled for a minor surgery.

Exclusion Criteria

My health status is severely or critically impaired.

I am hospitalized or in intensive care, which might affect how I feel or show pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I - Initial Assessment

Initial assessment of the institution's pain management in healthy pediatric patients undergoing ambulatory surgical procedures

2-4 weeks

Phase II - Randomized Trial

Randomized trial with intervention group receiving additional education on postoperative pain management

4 weeks

Follow-up

Participants are monitored for changes in pain management and behavior postoperatively

4 weeks

Treatment Details

Interventions

• Additional face-to-face education
• Standard of care management

Trial Overview The study compares standard post-surgery pain management to the same care plus extra education on what kind of pain to expect and how it will be managed. The goal is to see if additional information improves pain outcomes and satisfaction during recovery.

Participant Groups

Group I: Additional education Experimental Treatment 2 Interventions

Subjects undergoing ambulatory surgery who receive standard of care management with additional face-to-face education in postoperative pain management.

Group II: No additional education Active Control 1 Intervention

Subjects undergoing ambulatory surgery who receive standard of care management with no additional education in postoperative pain management.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Findings from Research

A study conducted in three Dutch hospitals revealed that there was a lack of consensus on postoperative pain management for 39 out of 48 common pediatric surgical procedures, which may lead to inconsistent treatment options and potential undertreatment of pain.

Nurses reported significantly higher postoperative pain scores than doctors for 15 out of the 48 procedures, highlighting a possible discrepancy in pain assessment and management between healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia in 3 Dutch hospitals: a pilot study]. Kokke, FT., van der Heide, DH., Boelen-van der Loo, WJ.[2008]

Effective pain management is crucial for children after surgery, as four out of five children experience significant pain postoperatively, which can have lasting negative effects on their health.

Recent advancements in pain management strategies have shown that children can undergo major surgeries with minimal adverse effects when proactive analgesia is provided, highlighting the importance of safe and easy-to-administer pain relief methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current management of pediatric postoperative pain. Kokki, H.[2005]

Postoperative pain relief in children is often inadequate, highlighting the need for improved pain management practices and assessment techniques.

Recent advancements in both pharmacological and nonpharmacological methods for managing postoperative pain in children are discussed, emphasizing the importance of effective pain assessment tools, especially for verbal children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and management of postoperative pain in children. Beyer, JE., Bournaki, MC.[2007]

A study involving 31 parents of children aged 3 months to 15 years showed that parents had high expectations for effective postoperative pain relief, but many children (29%) experienced severe pain or inadequate pain control within the first 24 hours after surgery.

To enhance pain management in pediatric patients, the study suggests developing an 'acute pain service' that focuses on better communication and effective use of existing pain management systems rather than relying on new technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain in children: a survey of parents' expectations and perceptions of their children's experiences. Rømsing, J., Walther-Larsen, S.[2019]

A systematic review of 337 randomized controlled trials on postoperative pain management in children revealed that most studies focused primarily on pain intensity and adverse events, but did not adequately incorporate the full range of outcomes recommended by the PedIMMPACT core outcome set.

Despite the publication of the PedIMMPACT guidelines in 2008, the uptake of these recommended outcomes in trials has not improved, which limits the ability to compare studies and synthesize evidence effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain in children and adolescents. Boric, K., Jelicic Kadic, A., Boric, M., et al.[2019]

Postoperative pain management in children is currently inadequate, not due to a lack of methods, but rather a lack of understanding and utilization of available techniques.

Effective pain management should be individualized for each child, with careful monitoring of pain levels and awareness of potential side effects from medications like opioids, non-steroidal anti-inflammatory drugs, and local anesthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative pain relief in children]. Hansen, TG., Henneberg, SW., Hole, P.[2006]

Multimodal analgesia, which includes the use of nonopioids like paracetamol and NSAIDs, is becoming increasingly important for managing pain in children after surgery, although more research is needed on the safety and efficacy of these treatments.

The use of regional analgesic techniques is expanding in pediatric postoperative care, focusing more on peripheral methods, which aligns with trends seen in adult pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative analgesia in pediatric surgery. Russell, P., von Ungern-Sternberg, BS., Schug, SA.[2022]

A survey of 1,500 anesthesia departments in Germany revealed that rectally administered acetaminophen is the standard for postoperative pain management in pediatric patients, with an increased use of opioids compared to past practices.

Despite the availability of various pain management options, 71.1% of anesthesiologists believe that postoperative pain management for children still requires improvement, indicating a need for better strategies and techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative pain therapy in pediatrics. Results of a representative survey in Germany]. Bremerich, DH., Neidhart, G., Roth, B., et al.[2019]

Postoperative pain management for children in Germany is currently inadequate due to a lack of standardized protocols and administrative responsibility, highlighting the need for improved practices.

The proposed concept emphasizes the surgeon's role in pain prevention through intraoperative nerve blocking and the importance of routine pain assessment, which has shown therapeutic success and efficiency when properly implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Perioperative pain therapy. Deficiencies in children and adolescents]. Till, H., Heinrich, M., Joppich, I.[2019]

A study involving 180 parents of children aged 6-18 who underwent orthopedic surgery revealed that most parents had low-to-moderate knowledge and negative attitudes towards pain management, despite their children experiencing significant pain.

The findings suggest that parents' pain relief strategies were influenced by their knowledge and attitudes, highlighting the need for targeted educational programs to improve parental understanding and practices in managing postoperative pain in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Postoperative Pain Management Perceptions, Attitudes, and Practices in Pediatric Limb Fractures. Zhang, SM., Chan, YY., Lai, LL., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia in 3 Dutch hospitals: a pilot study]. [2008]

2. England pubmed.ncbi.nlm.nih.gov

Current management of pediatric postoperative pain. [2005]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment and management of postoperative pain in children. [2007]

4. France pubmed.ncbi.nlm.nih.gov

Postoperative pain in children: a survey of parents' expectations and perceptions of their children's experiences. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain in children and adolescents. [2019]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Postoperative pain relief in children]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Perioperative analgesia in pediatric surgery. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Postoperative pain therapy in pediatrics. Results of a representative survey in Germany]. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Perioperative pain therapy. Deficiencies in children and adolescents]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Parental Postoperative Pain Management Perceptions, Attitudes, and Practices in Pediatric Limb Fractures. [2023]