Acute pain sustained by children suffering post traumatic extremity injuries can be quite harrowing experience for them. Oral analgesics provide relief from pain, and are commonly prescribed in the pediatric emergency setting before the implementation of narcotic medications. Of the many oral analgesics offered today, acetaminophen – codeine and ibuprofen are quite widely prescribed. There is little literature to indicate if acetaminophen – codeine or ibuprofen provides better pain relief in children. The article “Ibuprofen provides analgesia equivalent to acetaminophen – codeine in the treatment of acute pain in children with extremity injuries: a randomized clinical trial” (Friday, Kanegaye, McCaslin, Zheng and Harley 2009, p.711), aims to answer which of the two drugs provides better analgesia in children suffering acute extremity injuries. This essay aims to provide a critical appraisal using the Critical Appraisal Skills Program (CASP) questions for randomized controlled trials (Public Health Resource Unit, 2006) as headings. This essay will begin with a summary of the article and then go on to critically appraise the article using questions from CASP and a conclusion with a summary and reflection on the critique.
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Friday et al (2009) seeks to answer whether acetaminophen – codeine or ibuprofen provides better analgesia in children with extremity injuries. Over a period from November 2002 to February 2004, children between the ages 5 to 17 years of age were randomly assigned to a group prescribed acetaminophen – codeine or ibuprofen suffering traumatic extremity injuries. Written and informed consent was obtained before participants were randomized to a study group. In total 153 participants were assessed for suitability for the study. Of these 153, 68 participants were randomized, 34 to the acetaminophen – codeine group and 34 to the ibuprofen group. The children were randomly assigned to one of the two medication groups using a computer randomization process. Study envelopes were prepared by a person not involved in the study using sealed opaque envelopes containing prewritten prescriptions for either drug to avoid bias or inadvertent disclosure by the nurse administering the drug. Participants were then asked to rate their pain at baseline, 20, 40 and 60 minute intervals using a Color Analogue Scale (CAS). Of the 68 participants, only 2 participants belonging to the acetaminophen – codeine group were excluded from the final results due to benzodiazepine administration and improper data collection. The results show that there was little statistical difference between acetaminophen – codeine and ibuprofen in the treatment of extremity injuries in children; although ibuprofen was favored at the 20 and 40 minute interval and acetaminophen codeine was favored at the 60 minute mark.
1. Did the study ask a clearly-focused question?
The study has asked a clearly focused question in the title as to whether “Ibuprofen Provides Analgesia Equivalent to Acetaminophen-Codeine in the Treatment of Acute Pain in Children with Extremity Injuries”. The title also tells us that the population studied is children, the intervention given is analgesia, and the outcomes considered are a reduction in pain scores Friday et al (2009). The null hypothesis was that intergroup difference in mean pain score change at 40 minutes would exceed 2.0cm Friday et al (2009).
2. Was this a randomized controlled trial (RCT) and was it appropriately so?
The study was a randomized control trial. The study has been carried out as a double blinded randomized control study to assess whether ibuprofen provides the equivalent analgesia equivalence as acetaminophen – codeine in the treatment of acute pain in children with extremity injuries.
A double blinded randomized control study was the right way to approach the subject, of which of the two analgesics, provides better pain relief. Furthermore the authors tell us there is little literature written on the topic. There was no technical control to compare an intervention against.
3. Where participants appropriately allocated to intervention and control groups?
Subjects had to meet the inclusion criteria. The authors Friday et al (2009) tell us that the inclusion criteria to the trial were:
Patients who were 5 to 17 years of age who spoke English as a primary language, complained of an isolated of complained of an isolated extremity injury with tenderness to palpation from the clavicle or femoral neck to the distal phalanges, and reported pain intensity of at least 5 of 10 points at triage. (p.712)
Written and informed consent was obtained and then participants were assigned to the acetaminophen – codeine or ibuprofen treatment groups using a computer randomization process. Study packets were assembled with sealed opaque envelopes containing an order sheet directing the nurse to administer acetaminophen – codeine or ibuprofen Friday et al (2009).
The groups were well balanced, 64 subjects in total were enrolled into the study – 34 subjects were allocated to the acetaminophen codeine group and 34 patients to the ibuprofen group. This is a good indication that the randomization process was effective, and onset the groups were equivalent.
There were two patients excluded from the acetaminophen codeine group for protocol violation during the study which explains why there is a difference between the 2 groups from entry to trial reported.
However further information could have been provided concerning the computer randomization process. This would ensure the randomization process was effective.
4. Were participants, staff and study personnel ‘blind’ to participants study group?
The participants, staff and study personnel were blind to the participants study group with the exception of the nurse administering the drug. The study packets were assembled by a person not involved in the study using sealed opaque envelopes containing an order sheet directing the nurse to administer either drug in a developmentally appropriate formulation Friday et al (2009).
The study by Friday et al, also tells us that:
The medications were not identical in appearance, but were similar orange – hued liquids or white tablets administered as suppliedâ€¦
Although unblended, the nurse administering the study drug used a prewritten script to avoid inadvertent disclosure or bias. The patient, parent, investigator, and treating physician were unaware of the identity of the medication. The investigator and treating physician were not present at the time of medication administration. (p. 712).
Although every effort was made to achieve blinding in this study the issue of the nurse being aware of the medication being administered, raises the question if they passed on the information to the treating physician, researchers or participants which may have influenced bias in the results. Another issue which could have resulted in bias was the study medications were not identical, which could have resulted in bias, if identified by the participant or parent.
5. Were all of the participants who entered the trial accounted for at its conclusion?
All patients that were entered into the study were accounted for at its conclusion. Figure 1 (Friday et al., p.713) shows us the flow of participants throughout the study. The diagram shows us that 153 were enrolled into the study. Of these 153 participants 85 participants were excluded (70); due to exclusion/inclusion criteria (14); refused to participate and (1); due to ineligible location Friday et al (2009). There were 34 participants who were allocated to the acetaminophen – codeine group and 34 to the ibuprofen group. Excluded participants from analysis due to protocol totaled 2 in the acetaminophen group totaled 2, due to (1); improper data collection and (1); due to benzodiazepine administration. Of the 34 participants allocated to the ibuprofen group all participants were accounted for at the conclusion of the study. In regards to the acetaminophen – codeine group, the patients that were allocated to it is important for the two excluded participants to be analyzed despite any issues.
All participants were followed up to in each study group and I believe there is no evidence to suggest that there was loss to follow up.
All participants outcomes were analyzed to by the groups to which they were originally allocated.
6. Were all participants in all groups followed up and data collected in the same way?
Data that was collected from all groups in the study were followed up in the same way. The color analogue score (CAS) was used to assess baseline pain scores, then at 20 minute, 40 minute and 60 minute intervals. Furthermore we can assume participants were followed up to the 4 hour mark as the authors tell us “adverse reactions were infrequent and did not alter management: vomiting 4 hours after study medication and 1.5 hours after ketamine sedation” Friday et al (2009)
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7. Did the study have enough participants to minimize the play of chance?
The power calculation was 33 participants in each group to demonstrate therapeutic equivalence with alpha set at 0.05 and beta 0.10. This implies that 33 participants needed to be enrolled to either group for there to be any clinical significance as to whether which one of the drugs was more effective. Furthermore 2.0cm changes between the two groups would be clinically important to detect and that at 40 minutes the mean pain score would exceed 2.0 cm Friday et al (2009).The acetaminophen – codeine group did not meet with the calculated sample by 1 participant, which could explain why ibuprofen was the more preferred medication.
8. How are the results presented and what is the main result?
The results are presented to us as a mean change in pain score at 20, 40 and 60 minute intervals post medication administration, with a 95% confidence interval. The authors determined a significant result, was a reduction in CAS pain score of 2.0 cm or more Friday et al (2009). Figure 2 tells us that although ibuprofen was the preferred analgesic at the 20 and 40 minute and acetaminophen – codeine at the 60 minute mark there was less than 2.0 cm difference at all 3 intervals for there to be any clinical significance. The null hypothesis that the intergroup difference in mean pain score change at 40 minutes would exceed 2.0 cm Friday et al (2009). The authors Friday et al (2009) also tell us that:
We would reject the null hypothesis and consider the two drugs equivalent
if the 95% confidence interval (CI) centered on the observed difference in mean pain score changes lay between -2.0 and 2.0 cm. (p.713).
An issue that I have identified with the results and how they are presented is table 1 (p.712) , which outlines demographic characteristics, fails to list males in the table.
The bottom line results of the study tell us that acetaminophen – codeine and ibuprofen perform similarly in providing analgesia to children suffering extremity injuries.
9. How precise are the results?
The results are precise enough to make a decision that, administering acetaminophen – codeine or ibuprofen will provide similar analgesia to children suffering extremity injuries. A confidence interval is reported but no p value. Based on the results, the confidence interval at the upper and lower limit would not be enough for me to make a decision as to whether or not to use ibuprofen instead of acetaminophen – codeine. For myself to be able to make a decision a larger population would need to be randomized and reported on to be able to make an informed decision.
Were all the important outcomes considered so the results can be applied?
Working in adult acute emergency department were the majority of presentations are adolescent, adult and elderly, the setting in which the study took place differs greatly to my place of employment. The treatment could be applied in my workplace, but given the differences between adults and children, the probability of the acetaminophen – codeine or ibuprofen being sub therapeutic would be a great risk in the adult population.
The authors Friday et al (2009) tell us that:
One of our entry criteria was a minimum triage pain score of 5. While attempting to choose patients with the greatest potential for demonstrable improvement, we may have selected a population with painful conditions inadequately treated by the oral route. (p 716).
The above statement is evidence that individuals, policy makers, family/carers and the
Wider community may not be willing for this intervention to be implemented.
A randomized control trial as to whether ibuprofen provides analgesia equivalent to acetaminophen – codeine in the treatment of extremity injuries in children was the correct way in which to answer the question put forward by Friday et al (2008). The issue of the medications not being identical in appearance poses the question as to whether there was any bias in the results. Another issue was the minimum triage pain score of 5 and the administration of oral analgesia raises ethical questions which were not adequately addressed in the study. Little information was given on the randomization process and how patients were allocated to each group. The overall sample size was too small in my opinion, to be able to substantiate the authors conclusion that acetaminophen – codeine and ibuprofen provides similar performance in analgesia effectiveness. The implementation of ibuprofen in extremity injuries in children may be better suited to have the medication prescribed as break through pain relief or as a triage analgesic Friday et al (2008).
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