Short-term Effects of Intravenous Dexketoprofen Trometamol and Tramadol on Perfusion-Related Physiological Parameters in Renal Colic
Phase: NA
Conditions: Renal Colic
Sponsor: Ataturk University

Short-term Effects of Intravenous Dexketoprofen Trometamol and Tramadol on 
Perfusion-Related Physiological Parameters in Renal Colic 
Short-term Perfusion Effects: Dexketoprofen/Tramadol 
 
 
METHODS 
Study design and setting 
This single-centre, prospective, randomised study was conducted in the emergency department 
of Atatürk University Research and Training Hospital between November 2024 and April 2025. 
Adult patients aged 18–55 years presenting with flank pain and diagnosed with renal colic based 
on clinical evaluation and appropriate imaging were screened for eligibility. 
Participants 
Patients who met the inclusion criteria were required to have a Glasgow Coma Scale score of 
15, spontaneous respiration, and the capacity to provide informed consent. Exclusion criteria 
encompassed pregnancy or breastfeeding, chronic kidney disease, known allergy to study 
medications, chronic respiratory disease, hemodynamic instability, acute intoxication, 
uncontrolled epilepsy, or recent monoamine oxidase inhibitor use.  
Randomisation and interventions 
Participants were randomly assigned to one of three groups in a 1:1:1 ratio, receiving 
intravenous dexketoprofen trometamol (50 mg), tramadol (100 mg), or a combination of 
dexketoprofen trometamol (50 mg) and tramadol (50 mg). All medications were diluted in 100 
mL of normal saline and administered intravenously. The administration of rescue analgesia in 
the form of intravenous morphine (5 mg) was permitted at the discretion of the treating 
physician. 
Data collection and monitoring 
Physiological variables, including blood pressure, heart rate, oxygen saturation, respiratory rate, 
and EtCO2, were recorded at baseline (T0), 30 minutes (T30), and 60 minutes (T60). Arterial 
blood-gas analysis was performed at T0 and T60. The primary outcome of the study was a 
change in EtCO₂ over time, while secondary outcomes included changes in vital signs and 
blood-gas parameters. 
The primary outcome was the change in EtCO₂ over time (T0, T30, T60) and the comparison 
of these changes between the three analgesic groups as a surrogate marker of global tissue 
perfusion. Secondary outcomes encompassed the trajectories of heart rate, blood pressure and 
SpO₂ over time; changes in arterial blood gas parameters (pH, bicarbonate, PaCO₂, lactate and 

base deficit) between T0 and T60; and comparison of these physiological responses across 
treatment groups. 
Sample size and statistical analysis 
Sample size was calculated in G*Power using previously published data on EtCO₂ changes 
after tramadol or oxycodone administration (16). With α = 0.05 and 80% power, 34 patients per 
group (102 in total) were required.  
The analysis of the data was conducted utilising the SPSS version 25.0 software. The 
assessment of normality was conducted through histogram inspection and the implementation 
of the Shapiro–Wilk test. Continuous variables are presented as mean ± standard deviation or 
change over time, and categorical variables as counts and percentages. The alterations in vital 
signs and blood-gas variables occurring within and between the groups were subjected to 
analysis using repeated-measures ANOVA. For the purpose of comparing the between-group 
alterations, one-way ANOVA with Tukey post hoc tests were employed. Paired t tests were 
utilised for within-group comparisons between T0 and T60, and χ² tests were used for the 
analysis of categorical variables. Statistically speaking, a p value of less than 0.05 was deemed 
to be significant. 
Ethics Approval 
The study was approved by the Erzincan Binali Yıldırım University Clinical Research Ethics 
Committee (Decision No. 2024-16/01, 07 Nov 2024) and conducted in accordance with the 
Declaration of Helsinki. All participants provided written informed consent. 
CRediT authorship contribution statement 
G. D.: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, 
Resources, 
Software. 
M. G.: Conceptualization, Formal analysis, Investigation, Methodology, Resources, 
Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing. 
Declaration of Competing Interest 
The authors declare that they have no competing financial interests or personal relationships 
that could have influenced the work reported in this paper. 
Data availability statement 
The data that support the findings of this study are not publicly available due to privacy and 
ethical restrictions, as they contain identifiable patient information. 

Funding Statement 
No funding