Efficacy and Security of Combined Analgesia (Opioid and Anti-inflammatory Agent) to Control Pain in Children Seen in the Emergency Department for a Trauma of a Limb

Children's pain in Emergency Departments (ED) is poorly managed even though pain is one of the main symptoms of children consulting to the ED (Alexander et al., 2003; O'Donnell et al., 2002). Literature has repeatedly demonstrated the provision of analgesia to be suboptimal in the pediatric population in general. Friedland & Kulick (1994) reviewed medical records of 99 children with acute fractures assumed to be painful and found that only 53% received analgesia. Southall et al. (1993) showed that of 181 invasive procedures performed on children receiving intensive care, only 50 (28%) received additional analgesia or sedation and during 36 of these procedures the child grimaced or cried (In Maurice et al., 2002). Pain management practices by nurses and doctors in the emergency department (ED) are poor. Selbst & Clark (1990) noted that children (< 19 years) presenting with painful conditions in ED were much less likely to receive pain medications than adults (p = .001). Moreover, children were also less likely than adults to receive analgesics at discharge (p < .001). The authors concluded by mentioning that pediatricians and emergency physicians are reluctant to use analgesics for children in pain and needed additional education about management of acute pain. Recently, Brown et al. (2003) obtained similar results in a comparative chart review of adults and children presenting to the ED with a diagnostic of fracture. According to their results, children were least likely to receive any analgesics especially opioids. Compared with adults, a lower proportion (54%) of children (< 15 years) received an opioid (p < .001).

Moreover, results of the PAMPER study (Le May et al., 2005; Le May et al., 2007) revealed that on 150 children who presented themselves in ED for either a fracture, a severe sprain, a burn, an acute abdomen or deep lacerations, nurses and physicians only documented pain on 58% (87/150) of these children, even though these diagnoses are known to generate moderate to severe pain (> 4/10). Treatment of children presenting to the ED with a simple fracture is also poorly managed. Results from the same study showed that only 4 children out of 28 (14%) who presented to the ED with a simple fracture received an analgesic.

Efficacy of several medications has been verified to relieve pain of limb injuries in children consulting to the ED. Results of those studies show that ibuprofen was effective to relieve pain. But, most of these studies had a small sample size which affects their power to generalize their results (Koller et al., 2007; Tanabe et al. 2002). Only the RCT performed by Clark et al. (2007) demonstrated that ibuprofen (10 mg/kg) was more effective, at 60-minute post-administration, than both acetaminophen 15 mg/kg) and codeine (1 mg/kg) alone, to relieve children's pain following a musculoskeletal trauma. This trial had a total sample of 300 patients under 18-year with 100 patients per group. Nevertheless, only 52% of the group of children who received ibuprofen considered that their pain was well managed. On the other hand, it is important to specify that we are aware that codeine is pro-drug and necessitates the co-enzyme 2D6 of the CYP 450 to release morphine the analgesic component. Close to 12% of the Caucasian population do not have this co-enzyme, so codeine is not effective to relieve their pain (Williams et al., 2002). Nevertheless, since it is not part of the emergency physicians' practices at our ED to prescribe an opioid for a limb trauma, we needed evidence-based data to prove that a combination of medication would help decrease pain intensity. Further, this study is the first done at our ED using a combination of analgesics implying an opioid, so we needed to start with a weaker and safer opioid such as codeine.

Kennedy (2004) and Mehlisc (2002) propose the use of a combination of analgesics (opioid and non-steroidal inflammatory drug-NSAID) to better relieve children's pain generated by a musculoskeletal trauma. Their rationale is based on the potential of the NSAID to block pain impulses peripherically and decrease edema and the potential for the opioid to block pain at the level of the nervous central system. Finally, very few studies verified the efficacy of a combination of analgesics to relieve the pain generated by a limb trauma. An exhausted review of the literature did not retrieve any study comparing the efficacy of a combination of codeine and ibuprofen with ibuprofen alone to relieve musculoskeletal pain of children consulting to the ED.

Design: Randomized controlled trial (double blind) with the experimental group receiving codeine + ibuprofen and the control group receiving ibuprofen + placebo. Single site study.