Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000666426
Ethics application status
Approved
Date submitted
14/05/2025
Date registered
24/06/2025
Date last updated
24/06/2025
Date data sharing statement initially provided
24/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of different doses of dexmedetomidine combined with ketamine for managing pain after elective caesarean section
Scientific title
Randomized controlled trial comparing three doses of dexmedetomidine combined with fixed-dose ketamine for postoperative pain control following elective lower segment caesarean section under spinal anesthesia
Secondary ID [1] 314425 0
None
Universal Trial Number (UTN)
Trial acronym
C-DEXKET Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain after caesarean section 337442 0
Condition category
Condition code
Reproductive Health and Childbirth 333813 333813 0 0
Childbirth and postnatal care
Anaesthesiology 334027 334027 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Dexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr
Arm B: Dexmedetomidine 0.3 µg/kg/hr + Ketamine 0.25 mg/kg/hr
Arm C: Dexmedetomidine 0.4 µg/kg/hr + Ketamine 0.25 mg/kg/hr

Mode of administration: Intravenous infusion

Duration: Postoperative period (up to 24 hours post-surgery)

Setting: Postoperative care following elective caesarean section at Fatima Memorial Hospital, Lahore

Personnel: Administered by trained anesthesiology staff

Standardized co-analgesia: Paracetamol 1g IV every 8 hours; Nalbuphine 0.1 mg/kg IV rescue if VAS >5

Monitoring: VAS score, heart rate, blood pressure, SpO2 at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours
Intervention code [1] 331031 0
Treatment: Drugs
Comparator / control treatment
Arm A (Dexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr) will be used as the reference comparator arm for analysis.
Control group
Dose comparison

Outcomes
Primary outcome [1] 341416 0
Mean postoperative pain score
Timepoint [1] 341416 0
Pain scores assessed at 0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively (Primary timepoint: mean across all timepoints, with particular emphasis on 8-hour and 24-hour marks)
Secondary outcome [1] 447443 0
Total dose of rescue analgesia (Nalbuphine) required within 24 hours
Timepoint [1] 447443 0
24 hours postoperative
Secondary outcome [2] 447444 0
Time to first rescue analgesic dose
Timepoint [2] 447444 0
Continuous monitoring up to 24 hours postoperative
Secondary outcome [3] 447445 0
Heart Rate
Timepoint [3] 447445 0
Continuous monitoring for 24 hours postoperatively
Secondary outcome [4] 448559 0
Systolic and Diastolic Blood Pressure
Timepoint [4] 448559 0
Recorded at fixed intervals (0, 2, 4, 6, 8, 12, 16, 20, 24 hours) by trained staff using non-invasive blood pressure monitors and charted on postoperative data collection forms.
Secondary outcome [5] 448560 0
Oxygen Saturation (SpO2)
Timepoint [5] 448560 0
Continuous monitoring for 24 hours postoperatively

Eligibility
Key inclusion criteria
Pregnant females aged 18–50 years

Undergoing elective lower segment caesarean section under subarachnoid (spinal) block

Willing to participate and provide informed consent
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to dexmedetomidine or ketamine
Comorbidities (e.g., cardiac disease, epilepsy, COPD, adrenal insufficiency, malignancy)
Psychiatric disorders or chronic opioid use
Emergency surgeries
Indwelling epidural catheter or unmanageable pain levels

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelope technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/05/2025
Date of last participant enrolment
Anticipated
16/08/2025
Actual
Date of last data collection
Anticipated
18/08/2025
Actual
Sample size
Target
90
Accrual to date
33
Final
Recruitment outside Australia
Country [1] 27060 0
Pakistan
State/province [1] 27060 0
Punjab

Funding & Sponsors
Funding source category [1] 318919 0
Hospital
Name [1] 318919 0
Fatima Memorial Hospital, Lahore — Department of Anesthesiology (In-kind support: facilities, staff time, and equipment)
Country [1] 318919 0
Pakistan
Primary sponsor type
Individual
Name
Ahmed Naeem at Department of Anesthesiology, Fatima Memorial Hospital, Lahore
Address
Country
Pakistan
Secondary sponsor category [1] 321388 0
None
Name [1] 321388 0
Address [1] 321388 0
Country [1] 321388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317536 0
FMH College of Medicine & Dentistry Institutional Review Board
Ethics committee address [1] 317536 0
Ethics committee country [1] 317536 0
Pakistan
Date submitted for ethics approval [1] 317536 0
27/03/2025
Approval date [1] 317536 0
15/05/2025
Ethics approval number [1] 317536 0
FMH-27/03/2025-IRB-1636

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141358 0
Dr Ahmed Naeem
Address 141358 0
Department of Anesthesia, Fatima Memorial Hospital, Shadman Road, Lahore - 54000, Punjab, Pakistan
Country 141358 0
Pakistan
Phone 141358 0
+923114681512
Fax 141358 0
Email 141358 0
[email protected]
Contact person for public queries
Name 141359 0
Ahmed Naeem
Address 141359 0
Department of Anesthesia, Fatima Memorial Hospital, Shadman Road, Lahore - 54000, Punjab, Pakistan
Country 141359 0
Pakistan
Phone 141359 0
+923114681512
Fax 141359 0
Email 141359 0
[email protected]
Contact person for scientific queries
Name 141360 0
Ahmed Naeem
Address 141360 0
Department of Anesthesia, Fatima Memorial Hospital, Shadman Road, Lahore - 54000, Punjab, Pakistan
Country 141360 0
Pakistan
Phone 141360 0
+923114681512
Fax 141360 0
Email 141360 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data will be used solely for internal analysis and publication purposes; no current plan for data sharing.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    Consent.pdf
Ethical approval    DOC-20250519-WA0014..pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.