Synergistic Effect Of Parenteral Diclofenac And Paracetamol In The Pain Management Of Acute Limb Injuries
Condition: Musculoskeletal Injury
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute limb injury is a common reason to visit an emergency department worldwide. Intense pain
      related to the injury is always a concern for an emergency physician and requires effective
      analgesia within the shortest possible time. Non-steroidal anti-inflammatory drugs (NSAIDs),
      opioids and paracetamol are the commonly used drugs in an emergency department. The choice of
      analgesia should be established by its efficacy, logistics involved and route of
      administration. There is good evidence about NSAIDs being the first line analgesia and
      paracetamol is reported to have the narcotic sparing effect, either alone or as an adjunctive
      treatment in different settings. The synergistic effect of paracetamol with diclofenac in
      acute limb injuries related pain management lacks good- quality evidence. Therefore
      investigators proposed a large, well designed, randomized double-blind trial to develop
      high-quality evidence. The study aims to assess the efficacy of paracetamol in addition to
      diclofenac, and compare the difference between oral and intravenous paracetamol
      administration in acute limb injuries in the emergency department.
    

Detailed description: 
      Injuries account for a large burden of mortality and morbidity in the state of Qatar and
      worldwide. Among all the acute injuries, limb injuries are very common. Immense pain of
      patients on presentation is the matter of concern and requires effective analgesia within the
      shortest possible time.

      Most patients with acute limb injuries are treated with, the commonly used analgesics like
      non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and paracetamol in the ED. The
      choice of analgesic should be established by its efficacy, logistics involved, and route of
      drug administration. Few studies reported that intravenous route is more effective than the
      intramuscular route, due to its faster absorption and ease of titration. In many ED's
      intramuscular injectable drugs like NSAIDs are commonly used. Being, readily available and
      technically faster to administer. There is concern about the use of IM diclofenac in some
      countries because of possible intramuscular complications; however, most are reported cases
      in a small proportion (<2 per million doses used). Oral medications are also very commonly
      used and usually self-administered by the patients with duration of onset being in minutes to
      an hour. There is good evidence about NSAIDs being the first line analgesic in the management
      of acute painful conditions such as renal colic. Intramuscular diclofenac is shown to provide
      safe, effective, and sustained pain relief in addition to being logistically easier to
      administer. Paracetamol being a centrally acting inhibitor of cyclooxygenases has been
      reported safe alternative to opioids and equally effective analgesic in the ED with fewer
      side effects and contraindications. In addition, paracetamol is reported to have the narcotic
      sparing effect, either alone or as an adjunctive treatment in different settings including
      post-op pain, cancer pain, and regional anesthesia. The synergistic effect of paracetamol
      with diclofenac in acute limb injury related- pain management lacks good-quality evidence.

      Hamad General Hospital Emergency Department (HGH-ED) is the major emergency department (ED)
      in Doha; Qatar; and offers tertiary level care for emergency conditions. It is also one of
      the busiest ED's in the world with an annual patient attendance of 0.5 million. Patients with
      acute limb injuries account for about 25% of the total ED visits. At HGH-ED, intramuscular
      diclofenac is the analgesia of choice for the management of acute pain of moderate to severe
      intensity. However, 40-50% of these patients require additional analgesia in the form of
      opioids or paracetamol. The efficacy of combined analgesia approach, and the difference by
      route of drug administration in acute ED pain management is yet to be assessed. Therefore
      investigators proposed a large, well designed, randomized, double- blind trial to develop
      high-quality evidence. This study aims to assess the efficacy of paracetamol in addition to
      diclofenac, and compare the difference between oral and intravenous paracetamol
      administration in acute limb injury pain management in the ED.
    

Intervention name(s): Diclofenac and Paracetamol
Intervention type(s): Drug
Intervention description(s): analgesic effect of diclofenac along with either Oral versus Intravenous paracetamol versus placebo
Other intervention name(s): Placebo
Intervention MeSH terms: Acetaminophen; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Combination 1- Diclofenac Placebo Paracetamol (Oral) Combination 2- Diclofenac Paracetamol (IV) Placebo Combination 3- Diclofenac Placebo Placebo
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment