Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04199572
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2019-12-12
Brief Title:
Synergistic Effect Of Parenteral Diclofenac And Paracetamol In The Pain Management Of Acute Limb Injuries
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
Synergistic Effect Of Parenteral Diclofenac And Paracetamol In The Pain Management Of Acute Limb Injuries
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 EDs 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 EDs in the world with an annual patient attendance of 05 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
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 EDs 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 EDs in the world with an annual patient attendance of 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None