Musculoskeletal InjuryPhase 4NCT04199572
Synergistic Effect Of Parenteral Diclofenac And Paracetamol In The Pain Management Of Acute Limb Injuries
A Phase 4 study testing Diclofenac and Paracetamol in people with Musculoskeletal Injury, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Diclofenac and Paracetamol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteQatar
- Study dates
- 16 Oct 2022to 21 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years upto 65 years
- Vitals Stable
- musculoskeletal limb injury
- initial pain score of 5 or more on a NRS (numerical rating scale)
Who cannot join
- Patient received any pain medication prior to 8 hours
- Allergies to either diclofenac or paracetamol
- Contraindication to the study drugs
- CVA
- Bronchial asthma
- GI bleeding
Show all 10Show fewer
- Renal impairment
- Asthma
- Pregnancy and nursing
- Unstable traumatic patient
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Musculoskeletal Injury
- Being tested
- Diclofenac and Paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac and ParacetamolDrug
Also called Placebo
analgesic effect of diclofenac along with either Oral versus Intravenous paracetamol versus placebo
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac and Oral Paracetamol | Experimental | Diclofenac (75mg intramuscular), Placebo (100ml intravenous Normal Saline), Paracetamol (per oral 1gm) Receives: Drug: Diclofenac and Paracetamol |
| Diclofenac and IV Paracetamol | Experimental | Diclofenac (75mg intramuscular), Paracetamol (intravenous1gm in 100ml solution), Placebo (sugar tablets) Receives: Drug: Diclofenac and Paracetamol |
| Diclofenac and Placebo | Experimental | Diclofenac (75mg intramuscular),Placebo (100ml intravenous Normal Saline),Placebo (sugar tablets) Receives: Drug: Diclofenac and Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the difference in mean pain reduction amongst the three groups: numerical rating scale
Pain score on a numerical rating scale (NRS). The scale is a 11 point scale where 0 is no pain and 10 is the worst pain ever.
Measured: 30 minutes
Secondary outcomes (4)
To compare the difference in proportion of patients achieving 50% or more pain relief amongst the three groups
Pain score on a numerical rating scale (NRS). The scale is a 11 point scale where 0 is no pain and 10 is the worst pain ever.
Measured: 30 minutes
Requirement of rescue analgesia in each group of participants
Pain score on a numerical rating scale (NRS). The scale is a 11 point scale where 0 is no pain and 10 is the worst pain ever.
Measured: 30 minutes
The adverse event rate in three groups
any adverse event recorded
Measured: 90 minutes
Time to analgesia effect, to achieve 50% reduction, and to NRS <=2
Pain score on a numerical rating scale (NRS). The scale is a 11 point scale where 0 is no pain and 10 is the worst pain ever.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start16 Oct 2022
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Combination 1- Diclofenac Placebo Paracetamol (Oral) Combination 2- Diclofenac Paracetamol (IV) Placebo Combination 3- Diclofenac Placebo Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Isma Qureshi, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199572
- Sponsor's protocol ID
- IRGC-04-NI-17-099
- Status last verified
- Feb 2023
- First submitted
- 12 Dec 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tramer MR, Williams JE, Carroll D, Wiffen PJ, Moore RA, McQuay HJ. Comparing analgesic efficacy of non-steroidal anti-inflammatory drugs given by different routes in acute and chronic pain: a qualitative systematic review. Acta Anaesthesiol Scand. 1998 Jan;42(1):71-9. doi: 10.1111/j.1399-6576.1998.tb05083.x.
PubMed 9527748Khalili G, Janghorbani M, Saryazdi H, Emaminejad A. Effect of preemptive and preventive acetaminophen on postoperative pain score: a randomized, double-blind trial of patients undergoing lower extremity surgery. J Clin Anesth. 2013 May;25(3):188-92. doi: 10.1016/j.jclinane.2012.09.004. Epub 2013 Apr 6.
PubMed 23567482Aarons L, Ogungbenro K. Optimal design of pharmacokinetic studies. Basic Clin Pharmacol Toxicol. 2010 Mar;106(3):250-5. doi: 10.1111/j.1742-7843.2009.00533.x. Epub 2010 Jan 20.
PubMed 20102362Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. doi: 10.2105/ajph.90.4.523.
PubMed 10754963Macintyre PE, Schug SA, Scott DA. Acute pain management: the evidence grows. Med J Aust. 2006 Feb 6;184(3):101-2. doi: 10.5694/j.1326-5377.2006.tb00144.x.
PubMed 16460291Tveita T, Thoner J, Klepstad P, Dale O, Jystad A, Borchgrevink PC. A controlled comparison between single doses of intravenous and intramuscular morphine with respect to analgesic effects and patient safety. Acta Anaesthesiol Scand. 2008 Aug;52(7):920-5. doi: 10.1111/j.1399-6576.2008.01608.x.
PubMed 18702754Tuomilehto H, Kokki H. Parenteral ketoprofen for pain management after adenoidectomy: comparison of intravenous and intramuscular routes of administration. Acta Anaesthesiol Scand. 2002 Feb;46(2):184-9. doi: 10.1034/j.1399-6576.2002.460211.x.
PubMed 11942868Hindle A, Spedding R. Managing acute renal colic. Intramuscular diclofenac should be avoided. BMJ. 2003 Mar 1;326(7387):502. doi: 10.1136/bmj.326.7387.502. No abstract available.
PubMed 12609956Wright PJ, English PJ, Hungin AP, Marsden SN. Managing acute renal colic across the primary-secondary care interface: a pathway of care based on evidence and consensus. BMJ. 2002 Dec 14;325(7377):1408-12. doi: 10.1136/bmj.325.7377.1408. No abstract available.
PubMed 12480861Moran CP, Courtney AE. Managing acute and chronic renal stone disease. Practitioner. 2016 Feb;260(1790):17-20, 2-3.
PubMed 27032222Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA. Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16.
PubMed 26993881Babl FE, Theophilos T, Palmer GM. Is there a role for intravenous acetaminophen in pediatric emergency departments? Pediatr Emerg Care. 2011 Jun;27(6):496-9. doi: 10.1097/PEC.0b013e31821d8629.
PubMed 21629146Serinken M, Eken C, Turkcuer I, Elicabuk H, Uyanik E, Schultz CH. Intravenous paracetamol versus morphine for renal colic in the emergency department: a randomised double-blind controlled trial. Emerg Med J. 2012 Nov;29(11):902-5. doi: 10.1136/emermed-2011-200165. Epub 2011 Dec 20.
PubMed 22186009Craig M, Jeavons R, Probert J, Benger J. Randomised comparison of intravenous paracetamol and intravenous morphine for acute traumatic limb pain in the emergency department. Emerg Med J. 2012 Jan;29(1):37-9. doi: 10.1136/emj.2010.104687. Epub 2011 Mar 1.
PubMed 21362724Bektas F, Eken C, Karadeniz O, Goksu E, Cubuk M, Cete Y. Intravenous paracetamol or morphine for the treatment of renal colic: a randomized, placebo-controlled trial. Ann Emerg Med. 2009 Oct;54(4):568-74. doi: 10.1016/j.annemergmed.2009.06.501. Epub 2009 Jul 31.
PubMed 19647342
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effect Of Parenteral Diclofenac And Paracetamol In The Pain Management Of Acute Limb Injuries
- ClinicalTrials.gov ID
- NCT04199572
- Acronym / sponsor ID
- IRGC-04-NI-17-099
- Conditions
- Musculoskeletal Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Combination 1- Diclofenac Placebo Paracetamol (Oral) Combination 2- Diclofenac Paracetamol (IV) Placebo Combination 3- Diclofenac Placebo Placebo
| Arm | Type | Receives |
|---|---|---|
| Diclofenac and Oral Paracetamol | Experimental | Drug: Diclofenac and ParacetamolDiclofenac (75mg intramuscular), Placebo (100ml intravenous Normal Saline), Paracetamol (per oral 1gm) |
| Diclofenac and IV Paracetamol | Experimental | Drug: Diclofenac and ParacetamolDiclofenac (75mg intramuscular), Paracetamol (intravenous1gm in 100ml solution), Placebo (sugar tablets) |
| Diclofenac and Placebo | Experimental | Drug: Diclofenac and ParacetamolDiclofenac (75mg intramuscular),Placebo (100ml intravenous Normal Saline),Placebo (sugar tablets) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years upto 65 years
- Vitals Stable
- musculoskeletal limb injury
- initial pain score of 5 or more on a NRS (numerical rating scale)
Key exclusion criteria (10 listed)
- Patient received any pain medication prior to 8 hours
- Allergies to either diclofenac or paracetamol
- Contraindication to the study drugs
- CVA
- Bronchial asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac and ParacetamolAlso: Placeboanalgesic effect of diclofenac along with either Oral versus Intravenous paracetamol versus placebo | Drug | Diclofenac and IV Paracetamol, Diclofenac and Oral Paracetamol, Diclofenac and Placebo |
Primary outcome
To compare the difference in mean pain reduction amongst the three groups: numerical rating scale
Time frame: 30 minutes
Pain score on a numerical rating scale (NRS). The scale is a 11 point scale where 0 is no pain and 10 is the worst pain ever.
4 secondary outcomes
To compare the difference in proportion of patients achieving 50% or more pain relief amongst the three groups
Time frame: 30 minutes
Requirement of rescue analgesia in each group of participants
Time frame: 30 minutes
The adverse event rate in three groups
Time frame: 90 minutes
Time to analgesia effect, to achieve 50% reduction, and to NRS <=2
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 9527748Tramer MR, Williams JE, Carroll D, Wiffen PJ, Moore RA, McQuay HJ. Comparing analgesic efficacy of non-steroidal anti-inflammatory drugs given by different routes in acute and chronic pain: a qualitative systematic review. Acta Anaesthesiol Scand. 1998 Jan;42(1):71-9. doi: 10.1111/j.1399-6576.1998.tb05083.x.
- Background: PubMed 23567482Khalili G, Janghorbani M, Saryazdi H, Emaminejad A. Effect of preemptive and preventive acetaminophen on postoperative pain score: a randomized, double-blind trial of patients undergoing lower extremity surgery. J Clin Anesth. 2013 May;25(3):188-92. doi: 10.1016/j.jclinane.2012.09.004. Epub 2013 Apr 6.
- Results publication: PubMed 20102362Aarons L, Ogungbenro K. Optimal design of pharmacokinetic studies. Basic Clin Pharmacol Toxicol. 2010 Mar;106(3):250-5. doi: 10.1111/j.1742-7843.2009.00533.x. Epub 2010 Jan 20.
- Results publication: PubMed 10754963Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. doi: 10.2105/ajph.90.4.523.
- Results publication: PubMed 16460291Macintyre PE, Schug SA, Scott DA. Acute pain management: the evidence grows. Med J Aust. 2006 Feb 6;184(3):101-2. doi: 10.5694/j.1326-5377.2006.tb00144.x.
- Results publication: PubMed 18702754Tveita T, Thoner J, Klepstad P, Dale O, Jystad A, Borchgrevink PC. A controlled comparison between single doses of intravenous and intramuscular morphine with respect to analgesic effects and patient safety. Acta Anaesthesiol Scand. 2008 Aug;52(7):920-5. doi: 10.1111/j.1399-6576.2008.01608.x.
- Results publication: PubMed 11942868Tuomilehto H, Kokki H. Parenteral ketoprofen for pain management after adenoidectomy: comparison of intravenous and intramuscular routes of administration. Acta Anaesthesiol Scand. 2002 Feb;46(2):184-9. doi: 10.1034/j.1399-6576.2002.460211.x.
- Results publication: PubMed 12609956Hindle A, Spedding R. Managing acute renal colic. Intramuscular diclofenac should be avoided. BMJ. 2003 Mar 1;326(7387):502. doi: 10.1136/bmj.326.7387.502. No abstract available.
- Results publication: PubMed 12480861Wright PJ, English PJ, Hungin AP, Marsden SN. Managing acute renal colic across the primary-secondary care interface: a pathway of care based on evidence and consensus. BMJ. 2002 Dec 14;325(7377):1408-12. doi: 10.1136/bmj.325.7377.1408. No abstract available.
- Results publication: PubMed 27032222Moran CP, Courtney AE. Managing acute and chronic renal stone disease. Practitioner. 2016 Feb;260(1790):17-20, 2-3.
- Results publication: PubMed 26993881Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA. Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16.
- Results publication: PubMed 21629146Babl FE, Theophilos T, Palmer GM. Is there a role for intravenous acetaminophen in pediatric emergency departments? Pediatr Emerg Care. 2011 Jun;27(6):496-9. doi: 10.1097/PEC.0b013e31821d8629.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac and Paracetamol in people with Musculoskeletal Injury, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the difference in mean pain reduction amongst the three groups: numerical rating scale (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04199572, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.