A Phase 4 interventional study of Diclofenac/Tramadol in Acute Renal Colic, sponsored by Lampang Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Days and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Lampang Hospital · Phase 4, Interventional, and Treatment
Patients presented with acute pain from renal colic, the standard of care are prescribed NSAIDs, most common drug used is intramuscular (IM) Diclofenac injected at the gluteal muscle. Due to adverse effects in some patients, the nursing council has banned the injection by nurses. Since then, there has been a change in treatment by using intravascular (IV) Tramadol. According to various research, Diclofenac has a higher efficacy in controlling pain compared to other medications. In clinical practice, Tramadol has less efficacy of decreasing pain and a longer onset of action. At presence, there has been no research performed comparing the efficacy between these two drugs especially from the viewpoint of time dimension.
To compare the efficacy Diclofenac 75 mg IM versus Tramadol 50 mg IV in patients with acute pain from renal colic.
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's enrollment of 68 is below the median of 118 across 60 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →This is the only study on the registry with Lampang Hospital as lead sponsor.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Diclofenac 75 mg (3 ml) IM injection by doctor, then followed by normal saline 20 ml IV injection (equal to Tramadol diluted) by nurse.
Drug: Diclofenac/Tramadol
Normal saline 3 ml IM injection by doctor (equal to Diclofenac 75 mg), then followed by Tramadol 50 mg (1 ml) dilute with normal saline 19 ml (total 20 ml )IV injection by nurse.
Drug: Diclofenac/Tramadol
Drug pages: Diclofenac · Tramadol
Arm Drug1 :Diclofenac 75 mg (3 ml) IM injection by doctor, then followed by normal saline 20 ml IV injection (equal to Tramadol diluted) by nurse. Arm Drug2 :Normal saline 3 ml IM injection by doctor (equal to Diclofenac 75 mg), then followed by Tramadol 50 mg (1 ml) dilute with normal saline 19 ml (total 20 ml )IV injection by nurse.
Also known as: Fenac/Tramol
Diclofenac 75 mg IM or Tramadol 50 mg IV
Time to pain relief
Time frame: 30,60,90,120 minutes
Plan to share: No — Personal reasons
No publications or documents are linked to this record.
Ran from Apr 2022 to primary completion in Mar 2023, 11 months.
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Diclofenac · Tramadol