Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials

Prymula, Roman; Siegrist, Claire‐Anne; Chlíbek, Roman; Žemličková, Helena; Vacková, M; Smetana, Jan; Lommel, Patricia; Kaliskova, Eva; Borys, Dorota; Schuerman, Lode

doi:10.1016/s0140-6736(09)61208-3

Cited by 343 publications

(243 citation statements)

References 32 publications

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“…Our findings are consistent with those of Prymula et al 9 and, taken together, suggest that antipyretic agents should not be given prophylactically for infant immunization. Therefore, research on alternative pain-management strategies for immunization discomfort is urgently needed.…”

Section: Discussionsupporting

confidence: 93%

“…22 Therefore, longer sleep duration and increased temperature after immunization may be indicators of the degree of antibody responses. 9 Studies have suggested that sleep quantity is a potential mediator of antibody responses to vaccines in adults, perhaps through stressrelated modulation of cytokine production by activated T cells. 23,24 Although antibody development can take several weeks, 2 studies demonstrated that even relatively brief periods of sleep restriction could disrupt adult antibody responses.…”

Section: Discussionmentioning

confidence: 99%

“…5 Before 2009, infants commonly received prophylactic acetaminophen treatment to prevent immunization discomfort and fever, although there is a low level of evidence for effectiveness. [6][7][8] In 2009, Prymula et al 9 published data from a randomized controlled trial (RCT) that showed reduced immunogenicity when infants (3-5 months of age) received 3 doses of acetaminophen in the first 24 hours after primary vaccines. This led some authors to reconsider the practice, 10 whereas others advocated maintaining the current practice.…”

mentioning

confidence: 99%

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Infant Sleep After Immunization: Randomized Controlled Trial of Prophylactic Acetaminophen

2011

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WHAT'S KNOWN ON THIS SUBJECT:For adults, sleep deprivation before or after immunization is associated with decreased antigen-specific antibody formation, but little is known about infant sleep before and after immunization or the effects of prophylactic acetaminophen treatment on infant sleep. WHAT THIS STUDY ADDS:Infants demonstrated increased sleep duration in the 24 hours after immunization, particularly if they were immunized after 1:30 PM and had elevated temperatures. Acetaminophen use was associated with smaller increases in sleep duration but not when other factors were controlled. abstract OBJECTIVE: To determine the effects of acetaminophen and axillary temperature responses on infant sleep duration after immunization. METHODS:We conducted a prospective, randomized controlled trial to compare the sleep of 70 infants monitored by using ankle actigraphy for 24 hours before and after their first immunization series at ϳ2 months of age. Mothers of infants in the control group received standard care instructions from their infants' health care provider, and mothers of infants in the intervention group were provided with predosed acetaminophen and instructed to administer a dose 30 minutes before the scheduled immunization and every 4 hours thereafter, for a total of 5 doses. Infant age and birth weight and immunization factors, such as acetaminophen use and timing of administration, were evaluated for changes in infant sleep times after immunization. RESULTS:Sleep duration in the first 24 hours after immunization was increased, particularly for infants who received their immunizations after 1:30 PM and for those who experienced elevated temperatures in response to the vaccines. Infants who received acetaminophen at or after immunization had smaller increases in sleep duration than did infants who did not. However, acetaminophen use was not a significant predictor of sleep duration when other factors were controlled. CONCLUSIONS:If further research confirms the relationship between time of day of vaccine administration, increased sleep duration after immunization, and antibody responses, then our findings suggest that afternoon immunizations should be recommended to facilitate increased sleep in the 24 hours after immunization, regardless of acetaminophen administration.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Infant Sleep After Immunization: Randomized Controlled Trial of Prophylactic Acetaminophen

2011

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“…9,17,[37][38][39] In addition, results of 1 recent study suggested the possibility of decreased immune response to vaccines in patients treated early with antipyretics. 40 Although the available literature is limited on the actual risks of fever and the benefits of antipyretic therapy, it is recognized that improvement in patient comfort is a reasonable therapeutic objective. Furthermore, at this time, there is no evidence that temperature reduction, in and of itself, should be the primary goal of antipyretic therapy.…”

Section: Treatment Goalsmentioning

confidence: 99%

Fever and Antipyretic Use in Children

Sullivan¹,

Farrar²

2011

Pediatrics

363

313

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Fever in a child is one of the most common clinical symptoms managed by pediatricians and other health care providers and a frequent cause of parental concern. Many parents administer antipyretics even when there is minimal or no fever, because they are concerned that the child must maintain a “normal” temperature. Fever, however, is not the primary illness but is a physiologic mechanism that has beneficial effects in fighting infection. There is no evidence that fever itself worsens the course of an illness or that it causes long-term neurologic complications. Thus, the primary goal of treating the febrile child should be to improve the child's overall comfort rather than focus on the normalization of body temperature. When counseling the parents or caregivers of a febrile child, the general well-being of the child, the importance of monitoring activity, observing for signs of serious illness, encouraging appropriate fluid intake, and the safe storage of antipyretics should be emphasized. Current evidence suggests that there is no substantial difference in the safety and effectiveness of acetaminophen and ibuprofen in the care of a generally healthy child with fever. There is evidence that combining these 2 products is more effective than the use of a single agent alone; however, there are concerns that combined treatment may be more complicated and contribute to the unsafe use of these drugs. Pediatricians should also promote patient safety by advocating for simplified formulations, dosing instructions, and dosing devices.

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“…[6][7][8] However, an open label, randomized study by Prymula et al demonstrated that while acetaminophen (paracetamol) prophylaxis significantly reduced fever following routine childhood immunization, it simultaneously blunted the immune response to several vaccine antigens. 9 In this study, infants receiving primary immunization were divided into two groups, a prophylaxis group who received acetaminophen and a control group. The same allocation was maintained during the booster "secondary" immunizations.…”

Section: Introductionmentioning

confidence: 99%

Effect of antipyretic analgesics on immune responses to vaccination

Saleh

Moody

Walter

2016

Human Vaccines & Immunotherapeutics

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While antipyretic analgesics are widely used to ameliorate vaccine adverse reactions, their use has been associated with blunted vaccine immune responses. Our objective was to review literature evaluating the effect of antipyretic analgesics on vaccine immune responses and to highlight potential underlying mechanisms. Observational studies reporting on antipyretic use around the time of immunization concluded that their use did not affect antibody responses. Only few randomized clinical trials demonstrated blunted antibody response of unknown clinical significance. This effect has only been noted following primary vaccination with novel antigens and disappears following booster immunization. The mechanism by which antipyretic analgesics reduce antibody response remains unclear and not fully explained by COX enzyme inhibition. Recent work has focused on the involvement of nuclear and subcellular signaling pathways. More detailed immunological investigations and a systems biology approach are needed to precisely define the impact and mechanism of antipyretic effects on vaccine immune responses.

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Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials

Cited by 343 publications

References 32 publications

Infant Sleep After Immunization: Randomized Controlled Trial of Prophylactic Acetaminophen

Infant Sleep After Immunization: Randomized Controlled Trial of Prophylactic Acetaminophen

Fever and Antipyretic Use in Children

Effect of antipyretic analgesics on immune responses to vaccination

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