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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help children recover better after surgery by examining the impact of extra pain education. It compares two groups of children who have undergone surgery: one receives the usual care (standard of care management), while the other receives additional information about what to expect and how to manage pain (additional face-to-face education). The goal is to determine if the extra education aids in pain management and enhances overall satisfaction during recovery. This study is suitable for children aged 1-6 undergoing outpatient surgery and expected to return home within a day. As an unphased trial, it offers families a unique opportunity to contribute to improving post-surgery care for children.

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 prior data suggests that this education protocol is safe for children?

Research shows that teaching kids and parents about managing pain after surgery is safe and helpful. Studies have found that when families know what to expect, they manage pain better, leading to improved choices about pain relief at home.

Preoperative education, or learning before surgery, also helps reduce pain afterward. For example, children and their parents who watched videos or talked with someone felt more prepared and comfortable managing pain. This education is safe and provides extra information to improve pain management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance how children understand and manage pain after surgery. Unlike the standard approach that focuses on medication and basic care, this trial adds a personal touch with face-to-face education about pain management. This unique method could empower young patients and their families with more knowledge and confidence to handle post-surgery discomfort effectively. By potentially reducing reliance on medications through better education, this approach might lead to improved recovery experiences for children.

What evidence suggests that additional education is effective for managing post-surgery pain in children?

Research has shown that learning more about pain management can aid recovery after surgery. In this trial, some participants will receive standard care along with additional face-to-face education in postoperative pain management. Studies have found that pre-surgery education helps patients manage pain and increases satisfaction with their care. Involving families in the learning process can reduce anxiety and improve children's pain management. Educating children and their families about what to expect can significantly assist with post-surgery pain. Overall, providing extra face-to-face education may help children feel better and recover more smoothly after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Lena Sun, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

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The Impact of Preoperative Patient Education on ... Recent studies have shown that preoperative education can positively impact postoperative recovery, improving postoperative pain management and patient ...

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Children's Experiences With Pain and Pain-Relieving ... To explore children's experiences of pain and postoperative pain management in surgical wards. Methods. This qualitative explorative study used ...

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