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Evidence-Based Pediatric Pain

Terms
Clinical Trials In Pain Relief: 10 Challenges
Evidence-Based Pain Management For Infants
NICU Procedures
NICU Pain Protocol
NOPAIN Trial
EMLA and Newborns
Sucrose And Newborns
To Make a "24%" Sucrose Solution
Skin-To-Skin Contact as Analgesia
Pediatric Postoperative Pain
End Of Life: Pediatric Cancer
Effect Of Distraction on Pain
Pediatric Pain Measurement
Pediatric Acute vs Chronic Pain

Evidence-based practice
Deliberate use of current best evidence from theory, clinical expertise, and research in making decisions about patient care.
Consider cost effectiveness and patient practitioner preferences.
Randomized controlled (clinical) trial (RCT)
Experiment in which investigators randomly allocate eligible people into treatment and control groups to receive or not to receive one or more interventions that are being compared.
Results are assessed by comparing outcomes in treatment and control groups.
Systematic Review
Review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research and to collect and analyze data from the reviewed studies.
Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the reviewed studies.

Clinical Trials In Pain Relief: 10 Challenges

  1. Avoid unnecessary duplication of effort.

    Oxford Pain Internet Site: www.jr2.ox.ac.uk/Bandolier/painres/painpag//WOW/.

    Pain, Palliative and Supportive Care Cochrane Collaborative Review Group: www.cochrane.org

    Best Practice Network: www.best4health.org

  2. Use all existing trials to guide our clinical decisions.
  3. Improve the quality of RCTs in pain relief.
  4. Improve the quality of reporting the RCTs.
  5. Find better ways to present the results of trials to front-line users.
  6. Ensure that all RCTs, once completed, are promptly available to the users.
  7. Ensure that decision makers understand RCTs.
  8. Integrate findings of clinical trials with information from other types of research.
  9. Balance the findings of clinical research with other ways of knowing.
  10. Balance the findings of clinical trials with our values, preferences, and circumstances.
Reference: Jadad AR & Cepeda MS: Pain Clin Updates 7(2):1-4, 1999. Use of analgesia not related to NICU pain protocol

Evidence-Based Pain Management For Infants

Reference: Stevens B and Koren G: Curr Opin Pediatr 10:203-207, 1998.

NICU Procedures

Survey of 14 of 38 Canadian NICUs (11-93 to 2-94)
Daily logs of procedures/analgesia for 1 week

N = 239 infants (23 - 42 weeks)
Total of 2134 invasive procedures
Heelstick 1298/0
IV start 451/0
Venipuncture 179/0
Umbilical vessel cath 31/0
ll
Analgesia given 17 times for 7 procedures:
Arterial puncture 88\2
Et intubation 35\2
LP 28\1
Peripheral arterial line 6\4
Bladder cath 6\1
Chest tube insertion 5\3
Misc others 7\4

Analgesia given for other reason (eg, surgery) during 129 procedures
Total analgesia/anesthesia for 6.8% invasive procedures
Use of analgesia not related to NICU pain protocol

Reference: Johnston C and others: Clin J Pain 13(4):308-312, 1997.

NICU Pain Protocol

Retrospective chart review of 31
infants 25-41 weeks gestation, post abdominal surgery
N = 14 before pain protocol; PRN intermittent IV opioids
N = 15 after pain protocol; continuous IV opioids 24-48 hrs.

Outcomes post pain protocol: Reference: Furden S., and others: J Perinat Neonat Nurs, 12:58-69, 1998.

NO PAIN Trial

N = 69 neonates, 24-32 weeks' gestation intubated on ventilator for < 8 hours within 72 hours of birth
Continuous infusion Poor neurologic outcome * Deaths
1. MS 4% 0
2. Midazolam 32% 1
3. Dextrose 24% 2

* Intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL) by cranial ultrasound

Reference: Anand, KS and others: Arch Pediatr Adolesc Med 153:331-338, 1999.

EMLA And Newborns

Review: 11 studies, 9 RCTs
Ns: 13-110 (26 weeks to full-term)
Procedures:
circumcision (3)**
heel lancing (4)
venipuncture (1)**
venipuncture/arterial (1)**
lumbar puncture (1)
percutaneous venous cath (1)**

** Reduced physiologic / behavioral signs
No methemoglobinemia from single dose

Reference: Taddio A and others: Pediatrics 101(2):299, 1998.

Sucrose And Newborns

Review: 13 studies, all RCTs
Meta-analysis: 5 studies
N=271
4 term infants; 1 preterm
4 heel lance
1 venipuncture
1 circumcision


Placebo control: water or no intervention
Sucrose solutions: 3 - 50%
volume: 0.05 - 2 ml

Administered by dropper, syringe, or pacifier
Time before procedure: 0.5 - 3 min.


Results: dose of 2 ml of 12% sucrose effective
slight additional benefit from 24%
no additional benefit from > 24%
No adverse effects reported, but also not monitored


Reference: Stevens B and others: Acta Pediatr 86:837-842, 1997.

To Make a 24% Sucrose Solution

Skin-To-Skin Contact as Analgesia

N = 30 fullterm newborns
RCT: diapered infant whole body contact
against mother's chest
control: swaddled in crib
intervention 10 - 15 min.*** before heel lance and during and post 3 minutes after lance
Outcome measures: % of time crying and facial grimace and change in HR
Results: significantly reduced (P < .0001) outcome measures in contact group
crying reduced by 82%
grimacing reduced by 65%


*** Timing considered critical but variations not tested.

Reference: Gray L and others: Pediatrics 105(1): E14, Jan. 2000.

Pediatric Postoperative Pain

Prospective study of analgesic use and pain intensity on post-op day 1

3 hospitals in Spain ( 4-92 to 3-93)
N = 348 (3-14 years)
Reference: Banos JE and others: Eur J Pain 3:275-282, 1999.

End of Life: Pediatric Cancer

Survey of 103 parents whose child died of cancer (1990 -1997)
Interviews conducted average 3.1 years after death
Focused on quality of life during last month of life

Deaths: 79% progressive disease
21% treatment-related complication
49% in hospital; 45% in ICU
almost 50% of those in hospital had ventilator support during last 24 hr
Parental reports: 89% of children experienced substantial suffering from one of 4 problems:
fatigue, pain, dyspnea, poor appetite

Reference: Wolfe J and others: NEJM 342 (5):326-333, 2000.

Effect Of Distraction on Pain

Meta-analysis of 19 studies (17 RCT; 2 repeated measures)
N=535, ages 3-15 yr, M=6.6 yr.
Variety of distraction methods (e.g., music, party blower, kaleidoscope)
Variety of medical procedures (e.g., IV, LP, BMA, IM, dental)
Outcome measures: self-reported pain and/or observed behavioral distress
Results:
Pain - average effect size: 0.62 (= or - 0.42)
Measurement + sampling error: 35%
Distraction did not decrease perceived pain
Distress - average effect size: 0.33 (+ or - 0.17)
Measurement + sampling error: 74%
Distraction did decrease observed behavioral distress


Reference: Ref: Kleiber C & Harper DC: Nurs Res 48(1):44-49, 1999.

Pediatric Pain Measurement

Pediatric Acute vs. Chronic Pain



TAKE A PROJECT AND MAKE A DIFFERENCE

GOLDEN RULES FOR PAIN RELIEF

Whatever is painful to adults, is painful to children until proven otherwise.

Pain control must be based on scientific facts, not on personal beliefs or opinions.

References

Bibliography: Evidence Based Pediatric Pain

Practical Application Of Evidence-Based Practice

Guidelines For Pain Management During Newborn Circumcision

Guidelines For Atraumatic Skin/Vessel Punctures

Bibliography: Evidence Based Pediatric Pain

"Ouchless" Emergency Department (Kennedy & Luhmann, 1999)

Guidelines For Critical Review Of Pain Measurement Tools (Hester, 1993)

Guidelines For The Management Of Acute And Chronic Pain In Sickle Cell Disease (American Pain Society, 1999)

Quick Reference Guide For Clinicians: Acute Pain Management In Infants, Children And Adolescents: Operative And Medical Procedures (Agency For Health Care Policy And Research, 1992)

Cancer Pain Relief and Palliative Care in Children (WHO, 1998)

March 15, 2002

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