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Article Reviews and Commentary

Major Surgery Within the First Three Months of Life and Subsequent Biobehavioral Pain Responses to Immunizations at Later Age: A Case Comparison Study.
Peters, Koot, Boer et al Pediatrics 2003;111:129-135

The authors undertook this prospective matched-control study to examine whether or not major surgery with preemptive analgesia within the first three months of life altered the pain responses to immunizations at 14 or 45 months of age. Analgesia was provided by administration of morphine via continuous infusion or intermittent dosing. A secondary aim was to determine whether any alterations in pain responses were more pronounced in children with a larger number of negative hospital experiences.

Two groups of toddlers were compared: the index group had undergone major thoracic or abdominal surgery and received morphine post-operatively; the control group toddlers were matched by type of immunization and community health care pediatrician. The pain responses to immunizations were assessed using facial reaction, heart rate and saliva cortisol concentration. Negative hospital experiences included number of operations requiring postoperative morphine administration, cumulative Therapeutic Intervention Scoring System scores, and length of ICU stay or total days in hospital.

No differences were found between index and control groups in any of the measures used following administration of routine immunizations. The facial display of pain, anger or sadness or the salivary cortisol concentrations were not significantly different between the groups.

The authors concluded major surgery in combination with preemptive analgesia does not alter the pain response to subsequent pain exposures in toddlers.

Thomas J. Mancuso, MD, FAAP

The conclusions reached by the authors of this paper certainly are certainly heart-warming to pediatric anesthesiologists. This data is further indication of the importance of provision of postoperative analgesia to infants. In addition, the conclusions reached are in accord with many other investigations of the intraoperative care of infants and newborns wherein the provision of adequate anesthesia was associated with a host of salutary outcomes including decreased morbidity and even mortality.

This paper provides important information to those of us involved in the intra and postoperative care of infants undergoing major surgical procedures. Nevertheless, the use of routine immunizations as the painful stimuli to compare the toddlers' responses to pain deserves comment. EMLA and/or distraction were not used to alleviate the child's discomfort, although they were likely available at the time. The study was performed between 1/98 and 7/2000. This investigation, carried out in the Netherlands, might not have been approved the IRB on which I sit. According the current US federal regulations, which apply in the US to federally funded research involving human subjects and guide our IRB deliberations, the risk/benefit category into which the study would fall is greater than minimal risk with no prospect of direct benefit to the study participants. Regulation CFR46.407 would apply, requiring not only IRB review and deliberation but also consultation by the Secretary with a panel of experts, a period of public comment, the consent of both parents. The full regulation is included below for those interested.

46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

DHHS will conduct or fund research that the IRB does not believe meets the requirements of 46.404, 46.405, or 46.406 only if:

(a) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

(b) the Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:

(1) that the research in fact satisfies the conditions of 46.404, 46.405, or 46.406, as applicable, or (2) the following:

(i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

(ii) the research will be conducted in accordance with sound ethical principles;

(iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in 46.408.

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