Revisiting established medicines: An overview of systematic reviews about ibuprofen and paracetamol for treating pain in children

Abstract

Background and objective We explored how systematic reviews evaluated paracetamol and ibuprofen for treating pain in children, as these two non‐opioid analgesics are well‐established medicines included in most national essential medicines lists. Databases and data treatment We carried out an overview of systematic reviews (SRs) of randomized controlled trials (RCTs) of interventions (PROSPERO registration: 42016045367). We searched MEDLINE, EMBASE, Cochrane Database of Systematic Reviews (CDSR) and Database of Reviews of Effects (DARE) up to 23 August 2017. We used AMSTAR checklist to analyse methodological quality of included SRs. Results We found 17 SRs with 72 unique RCTs; the majority of those trials included under 100 children. Positive conclusive evidence was found in only one SR, regarding safety of paracetamol. Conclusions of other SRs for efficacy and safety of ibuprofen and paracetamol were inconclusive, unclear, or there was no opinion. Only one SR analysed efficacy of ibuprofen and other non‐steroidal anti‐inflammatory drugs (NSAIDs) in chronic pain and the conclusion was that there was no evidence from RCTs that NSAIDs were effective for chronic non‐cancer pain in children and adolescents. Most of the SRs addressed very narrow questions, included few trials, with few children and were of low or medium methodological quality. Conclusions Most SRs on two relevant medicines have inconsistent conclusions and doubt upon their effectiveness. Instead of focusing on very narrow questions, SRs should examine more comprehensive research topics to obtain a general sense of consistency, particularly when analysing established medicines. Significance Evidence behind two analgesics—ibuprofen and paracetamol—that are well‐established medicines for children in most countries appears limited, judging by the systematic reviews. The discrepancy between clinical use and the extensive evidence we reviewed may be a result of the selective criteria in the reviews examined. We need new, and better evidence syntheses supporting the use of these two medicines in wide indications regarding pain in children.

Effectiveness of treatments for acute and subacute mechanical non-specific low back pain: a systematic review with network meta-analysis

“…The evidence associated with NSAIDs goes beyond the trials included in this analysis because they have a well-established role in pain management. [50][51][52] Moreover, two recent systematic reviews that found evidence for reducing pain and disability with the use of muscle relaxants recommended caution in interpretation of the findings as the evidence cannot be generalised because only two muscle relaxants were studied. 43 53 Our analysis included a heterogeneous group of muscle relaxants (carisoprodol, thiocolchicoside, tizanidine) administered at different doses and for a short time.…”

Over-the-counter analgesics use is associated with pain and psychological distress among adolescents: a mixed effects approach in cross-sectional survey data from Norway

“…There is no evidence from randomized controlled trials to support or refute the use of Paracetamol [ 8 ] or Ibuprofen [ 9 ] to treat chronic forms of pain in children and adolescents, and no conclusions can be made about either efficacy or harm. A recent evaluation found multiple inconsistencies, heterogeneity and very narrow topics in the existing systematic reviews on Paracetamol and Ibuprofen use among children and adolescents up to the age of eighteen [ 10 ] and safety profile evaluations therefore require a broader scope. OTCA abuse is broadly defined as the systematic overuse of non-prescription medicine, and it is a serious global health challenge [ 11 , 12 ].…”

Post‐operative discomforts in children after extraction of primary teeth

“…Paracetamol (acetaminophen) is a common analgesic with high usage and availability (Radman et al, 2019). However, there is a risk of toxicity from overdose, and hypersensitivity reactions to paracetamol appear to be increasing (Rutkowski, Nasser, & Ewan, 2012).…”

“…Although several large observational studies confirm better side effect profiles for paracetamol compared with traditional non-steroidal anti-inflammatory drugs, every prescribing decision should involve a calculation of risk versus benefit, and when benefit is uncertain, more careful consideration of paracetamol usage is required (Berlin et al, 2019;Deshpande, Bhargava, & Gupta, 2014). Moreover, a recent systematic review of paracetamol in treating all types of pain in children reached the conclusion that even if paracetamol is recommended in most guidelines, high quality clinical trials are needed to generate better evidence regarding the efficacy of this analgesic for treating pain (Radman et al, 2019).…”