Analgesic Properties of Oral Sucrose During Routine Immunizations at 2 and 4 Months of Age

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Reported on Medscape, a study re vaccination/pain which is

distributed amongst doctors for their ongoing education.

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Vaccination is the most common procedure performed in infancy,

although parents might have significant concerns regarding the pain

associated with routine vaccinations. Moreover, painful experiences

very early in life can promote somatization later in life. Oral

sucrose has been demonstrated to reduce pain reactions among

neonates, and the current study examines this simple intervention

prior to administration of routine vaccination at 2 and 4 months of age.

Best Evidence Reference

Hatfield LA, Gusic ME, Dyer A, Polomano RC

Analgesic Properties of Oral Sucrose During Routine Immunizations at

2 and 4 Months of Age

Pediatrics. 2008;121:e327-e334

<http://www.medscape.com/medline/abstract/18245406>Abstract

The study that this review is based on was selected from Medscape

Best Evidence

<http://www.medscape.com/pages/features/newsletters/bestevidence/fmpc>Medscape

Best Evidence which uses the McMaster Online Rating of Evidence

System. Out of a possible top score of 7, this study was ranked as 6

for relevance and 5 for newsworthiness by clinicians who used this system.

Commentary

Routine vaccinations are the most common procedures performed during

infancy, and as recommendations for them have expanded to include

varicella and influenza, children may now receive up to 24 injections

by age 2. These vaccinations are critical to the prevention of

morbidity and mortality in children, and parental involvement and

consent is critical to achieve the goal of complete vaccination.

Parents generally agree with the need for vaccinations. In a study of

1600 parents completed in 1999, 87% of them believed that vaccination

is extremely important to keep children well, and 84% preferred not

to omit any required vaccines for their children.[1] However, 23% of

these parents felt that their children received more vaccinations

than was good for them, and one quarter of respondents feared that

too many vaccinations would weaken their child's immune system.

In another survey of parents, pain was their main concern regarding

childhood vaccination.[2] Increasing the number of vaccinations in a

single visit increased pain concerns among both parents and

physicians. However, the majority of parents continued to prefer one

visit for multiple vaccinations compared with several visits with

fewer injections per visit, even when 4 injections were required at one visit.

The pain incurred during vaccination may do more than promote

transient discomfort and parental anxiety. Some research has found

that pain during the neonatal period is associated with increased

sensitivity to pain during childhood, and animal studies suggest that

pain early in life may produce permanent alterations in neuroanatomy

and behavior.[3] In particular, neonates with a history of

prematurity may be prone to the dual deleterious effects of

prematurity and an increased number of painful procedures. In one

comparison of 36 children with premature delivery and extremely low

birth weight vs matched full-term controls, scores for somatization

were higher in the premature cohort at age 4-1/2 years.[4] Rates of

chronic illness were similar among the premature children with and

without somatization, suggesting a causative role for trauma during

the neonatal period.

Premature infants have been demonstrated to have increased pain

sensitivity that can extend even beyond childhood. In a comparison of

60 adolescents with a history of preterm delivery and 60 adolescents

delivered at full term, subjects with a history of preterm delivery

had a higher number of tender points (6.0 vs 3.3) and also a lower

pain threshold compared with subjects delivered at term.[5]

Despite data suggesting a long-term potential for complications

related to pain experienced during the neonatal period, the practice

of analgesia for this highly vulnerable population lags behind

recommendations.[3] In a 2003 study of 151 neonates in the intensive

care unit, the average number of procedures per day was 14, and 83.9%

of procedures were judged to be painful.[6] However, fewer than 35%

of neonates per study day received prophylactic analgesia, and 39.7%

of the neonates did not receive any analgesic therapy at all during

their stay in the intensive care unit. A 2006 review of whether oral

sucrose administration alleviated pain from minor procedures in

premature infants concluded that evidence was insufficient to draw

any conclusions. However, sucrose was effective in reducing the pain

response to single procedures among term infants.[7]

In the current study, the authors examined the effects analgesia on

term infants, a group that has received less scrutiny in terms of

trials of analgesia prior to painful procedures. Specifically, they

performed a randomized, controlled trial of sucrose administration on

healthy infants delivered between 37 and 42 weeks' gestation. All

infants were being seen for their routine vaccinations at ages 2 and

4 months. Infants who had been fed within 30 minutes of vaccination

were excluded from study participation.

Participants received either a 24% disaccharide solution at a dose of

0.6 mL/kg, or matching placebo. Infants were not swaddled, cuddled,

or restrained during vaccination or the ensuing data collection period.

Infants were assessed with the University of Wisconsin Children's

Pain Scale at baseline and 2, 5, 7, and 9 minutes after

administration of the study treatment. This 5-point scale measures

children's pain using multiple variables, including cry, facial

expression, behavior, and body movement, and is considered a valid

means of assessing pain because of the use of multiple domains of measurement.

Infants received the combined diphtheria-tetanus-acellular pertussis,

inactivated polio, and hepatitis B vaccine 2 minutes after receiving

the study solution. They then received the Haemophilus influenzae

type B vaccine 3 minutes later, and finally they received the

pneumococcal conjugate vaccine 2 minutes after the H influenzae vaccine.

There were 100 infants were enrolled in the study, and 83 provided

study data. Baseline data were similar between the sucrose and

control groups. The mean gestational age and birth weight were 39

weeks and 3.5 kg, respectively.

The infants' pain score peaked at 7 minutes, with mean scores of 3.80

and 4.81 in the sucrose and control groups, respectively. Sucrose was

more effective than control therapy at 2 minutes (mean difference in

pain score between sucrose and control treatment: -1.83), 5 minutes

(-1.34), 7 minutes (-1.01), and 9 minutes (-2.16). At 9 minutes, the

pain score had returned to near baseline in the sucrose group but

remained elevated at 2.91 in the control group.

The study authors calculate that the number of additional infants

needed to treat with sucrose vs placebo to achieve one more pain

score of 0 or 1 at 2 minutes was 4. The number needed to treat to

achieve a similar score at 9 minutes was only 2.

The most significant limitation of this study is that the vaccination

procedure did not reflect that of most clinical practices. Whereas

the separation of injections was important to standardize the current

study protocol and monitor reactions to individual vaccines, most

practices will perform all necessary vaccinations more rapidly in

succession. Sucrose might have been even more effective in such a

practice, assuming that sucrose produces a short, transient state of analgesia.

Sucrose has previously been demonstrated to improve outcomes among

neonates undergoing painful procedures. In an analysis of 21

randomized controlled trials involving 1616 infants, sucrose at a

wide range of doses (0.012 mg to 0.12 mg) improved the rate of crying

at 30 and 60 seconds after heel lance.[8] However, sucrose was not

effective in reducing heart rate at 1 and 3 minutes after heel lance.

Some practices employ other analgesic measures to reduce the pain of

pediatric vaccinations. The application of the lidocaine-prilocaine

patch prior to the first measles-mumps-rubella vaccine among children

at least 12 months of age resulted in a significant reduction in

Behavior Pain Scale scores vs placebo treatment.[9] Moreover, rates

of irritability after vaccination were 16% in the

lidocaine-prilocaine group vs 31% in the placebo group, and the

antibody responses in the 2 groups to the vaccine components were similar.

Parents may also pretreat their children with oral analgesic

medications prior to appointments for vaccination, and a study of

acetaminophen delivered prior to administration of the

diphtheria-pertussis-tetanus toxoids-polio vaccine largely supports

this practice.[10] Compared with placebo, acetaminophen reduced the

risk for fever greater than 38 degrees Celsius from 44% to 27%. Rates

of behavioral changes after vaccination were 0.9% among the

acetaminophen group vs 13% with placebo. However, acetaminophen was

superior to placebo for primary vaccinations at 2 to 6 months of age

but not for booster vaccination at 18 months of age. At the 18-month

vaccination, the overall rate of systemic and local reactions was

higher in both the acetaminophen and placebo groups. Another study

has demonstrated that neither acetaminophen nor ibuprofen was

effective in reducing the risk for local reactions such as erythema

and swelling following the fifth diphtheria-tetanus toxoids-acellular

pertussis vaccination.[11]

Two key questions remain regarding the implementation of sucrose for

the prevention of pain in pediatric vaccinations. First, the

weight-based dosing algorithm for sucrose in the current study

certainly appeared effective, but the dosage range used in different

studies has generally been quite wide. Further research should

address the issue of the optimal dose of sucrose. In addition, it

would be very easy to conceive that using other analgesics such as

acetaminophen in addition to sucrose could be synergistic in

improving pain and behavior after vaccination. Moreover, the use of

antipyretic medications could also reduce the risk for postvaccination fever.

Regarding the practical utility of different methods of analgesia for

routine infant vaccinations, lidocaine-prilocaine can be difficult to

apply and maintain in place for the 30 minutes required for effective

analgesia prior to procedures. Oral analgesics must also be delivered

well before the vaccine is administered to be effective, and they

expose infants and children to the remote possibility of significant

adverse events. In contrast, sucrose appears to be a readily

available and applicable means to reduce infants' pain with

vaccination. It is inexpensive and safe. Sucrose can also help

parents to feel actively involved in protecting their infant from

pain, and this should help increase acceptance of routine

vaccinations. And that outcome should taste just like sugar for clinicians.

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Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.wellwithin1.com/vaccine.htm

Vaccine Dangers & Homeopathy Online/email courses