Postoperative PainPhase 4KETODEX-CSNCT07022821
Comparison of Dexmedetomidine + Ketamine for Postoperative Pain in C-Section
A Phase 4 study testing Dexmedetomidine and ketamine in people with Postoperative Pain and Cesarean Section Pain, run by Fatima Memorial Hospital at 1 site in Pakistan.
Trial summary
This study aims to compare three different doses of dexmedetomidine, when combined with a fixed dose of ketamine, for pain control in women undergoing cesarean section. The goal is to find the most effective combination with the fewest side effects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postoperative Pain, Cesarean Section Pain
- What is being tested?
- Dexmedetomidine and ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 16 May 2025to 31 Aug 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Elective lower segment cesarean section
- American Society of Anesthesiologists (ASA) Physical Status II
- Provided informed consent
Who cannot join
- Known drug allergy
- Presence of significant comorbidities
- Emergency surgery
- Documented psychiatric illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Fatima Memorial Hospital
Lahore, Punjab Province, 54000
Ahmed Naeem, MBBS
About this study
Official title: Comparison of Different Doses of Dexmedetomidine in Combination With Ketamine for Control of Post-Operative Pain in Lower Segment Caesarean Section Surgeries
This study aims to compare three different doses of dexmedetomidine, when combined with a fixed dose of ketamine, for pain control in women undergoing cesarean section. The goal is to find the most effective combination with the fewest side effects.
Read the detailed description
Caesarean section is associated with moderate-to-severe postoperative discomfort in a significant proportion of women, which can delay recovery and return to regular activities, disrupt mother-child bonding, affect maternal psychological well-being, and impede nursing. Furthermore, inadequate surgical pain treatment may result in hyperalgesia and chronic pain. Due to widespread misconceptions that analgesic medications or procedures may have detrimental effects on the mother or newborn, and because the severity of post-caesarean section pain is typically underestimated, pain following caesarean section is frequently under-treated.
Various analgesic therapy techniques include oral or parenteral opioids, nonsteroidal anti-inflammatory medications, and neuraxial blocks with or without adjuvants, with unclear efficacy and/or substantial adverse effects. While opioids are the gold standard for postoperative pain management, they are associated with respiratory depression, nausea, vomiting, and other adverse effects that increase patient suffering. In recent years, there has been a shift toward minimizing opioid use and developing guidelines for enhanced postpartum recovery. Studies have explored combining opioids with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), ketamine, clonidine, and dexmedetomidine for effective pain relief while avoiding opioid-related side effects.
Dexmedetomidine, a highly selective α2-agonist, is beneficial in reducing tension and anxiety. It may be effective in the management of postoperative pain due to its analgesic properties. Dexmedetomidine acts at spinal and supraspinal sites, producing antinociceptive effects via stimulation of α2-receptors in the locus coeruleus.
Ketamine has been shown to be an effective painkiller with few side effects when used in small doses. Its analgesic effects result from N-methyl-D-aspartate (NMDA) receptor antagonism, and it also interacts with opioid receptors in the brain and spinal cord. When combined with benzodiazepines, ketamine's adverse effects are further minimized.
The combination of ketamine and dexmedetomidine offers several benefits, including hemodynamic stability, absence of respiratory depression, improved postoperative analgesia, and smoother recovery. Previous work has demonstrated a synergistic effect when these agents are used together, providing excellent symptom relief while minimizing side effects.
This study seeks to address the current gap in literature regarding the comparative efficacy of different doses of dexmedetomidine combined with a fixed dose of ketamine for post-cesarean analgesia. It aims to evaluate three infusion doses of dexmedetomidine combined with ketamine using postoperative pain scores as the primary outcome measure. The findings may help optimize pain management protocols following cesarean section
- Conditions
- Postoperative Pain, Cesarean Section Pain
- Being tested
- Dexmedetomidine, ketamine
- Keywords
- Cesarean Pain, Multimodal Analgesia, Spinal Anesthesia, Dexmedetomidine, Ketamine, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine infusion at one of the following doses:
Group A: 0.2 µg/kg/hr Group B: 0.3 µg/kg/hr Group C: 0.4 µg/kg/hr Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
ketamineDrug
Ketamine infusion at a fixed dose of 0.25 mg/kg/hr administered in all three groups.
Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Dexmedetomidine | Experimental | Dexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion Receives: Drug: Dexmedetomidine; Drug: ketamine |
| Medium-Dose Dexmedetomidine | Experimental | Dexmedetomidine 0.3 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion Receives: Drug: Dexmedetomidine; Drug: ketamine |
| High-Dose Dexmedetomidine | Experimental | Dexmedetomidine 0.4 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion Receives: Drug: Dexmedetomidine; Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Postoperative Pain Score (Visual Analog Scale)
Pain will be assessed using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain. Visual Analog Scale (VAS) scores will be recorded at 0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.
Measured: 0-24 hours post-surgery
Secondary outcomes (2)
Time to First Rescue Analgesia
Measured in hours from the end of surgery to the time when the first dose of rescue analgesia (Nalbuphine 0.1 mg/kg Intravenous) is administered. Time will be recorded prospectively by anesthesia staff using standardized postoperative monitoring sheets and confirmed from the medication administration records.
Measured: Continuous monitoring up to 24 hours postoperative
Total dose of rescue analgesia (Nalbuphine) required within 24 hours
Determined from direct observation and recorded in structured data collection forms by trained anesthesia personnel during the postoperative period. All doses of Nalbuphine administered will be documented in real-time and verified against the patient's medication administration records and nursing charts.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start16 May 2025
- Primary completion16 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Naeem, Fatima Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022821
- Sponsor's protocol ID
- FMH-KETODEX-CS-2025
- Acronym
- KETODEX-CS
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: VAS scores, rescue drug doses, vitals (de-identified)
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Doses of Dexmedetomidine in Combination With Ketamine for Control of Post-Operative Pain in Lower Segment Caesarean Section Surgeries
- ClinicalTrials.gov ID
- NCT07022821
- Acronym / sponsor ID
- KETODEX-CS / FMH-KETODEX-CS-2025
- Conditions
- Postoperative Pain, Cesarean Section Pain
- Keywords
- Cesarean Pain, Multimodal Analgesia, Spinal Anesthesia, Dexmedetomidine, Ketamine, Postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fatima Memorial HospitalUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 16 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 15 Jun 2025 (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.
This study aims to compare three different doses of dexmedetomidine, when combined with a fixed dose of ketamine, for pain control in women undergoing cesarean section. The goal is to find the most effective combination with the fewest side effects.
Detailed description
Caesarean section is associated with moderate-to-severe postoperative discomfort in a significant proportion of women, which can delay recovery and return to regular activities, disrupt mother-child bonding, affect maternal psychological well-being, and impede nursing. Furthermore, inadequate surgical pain treatment may result in hyperalgesia and chronic pain. Due to widespread misconceptions that analgesic medications or procedures may have detrimental effects on the mother or newborn, and because the severity of post-caesarean section pain is typically underestimated, pain following caesarean section is frequently under-treated.
Various analgesic therapy techniques include oral or parenteral opioids, nonsteroidal anti-inflammatory medications, and neuraxial blocks with or without adjuvants, with unclear efficacy and/or substantial adverse effects. While opioids are the gold standard for postoperative pain management, they are associated with respiratory depression, nausea, vomiting, and other adverse effects that increase patient suffering. In recent years, there has been a shift toward minimizing opioid use and developing guidelines for enhanced postpartum recovery. Studies have explored combining opioids with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), ketamine, clonidine, and dexmedetomidine for effective pain relief while avoiding opioid-related side effects.
Dexmedetomidine, a highly selective α2-agonist, is beneficial in reducing tension and anxiety. It may be effective in the management of postoperative pain due to its analgesic properties. Dexmedetomidine acts at spinal and supraspinal sites, producing antinociceptive effects via stimulation of α2-receptors in the locus coeruleus.
Ketamine has been shown to be an effective painkiller with few side effects when used in small doses. Its analgesic effects result from N-methyl-D-aspartate (NMDA) receptor antagonism, and it also interacts with opioid receptors in the brain and spinal cord. When combined with benzodiazepines, ketamine's adverse effects are further minimized.
The combination of ketamine and dexmedetomidine offers several benefits, including hemodynamic stability, absence of respiratory depression, improved postoperative analgesia, and smoother recovery. Previous work has demonstrated a synergistic effect when these agents are used together, providing excellent symptom relief while minimizing side effects.
This study seeks to address the current gap in literature regarding the comparative efficacy of different doses of dexmedetomidine combined with a fixed dose of ketamine for post-cesarean analgesia. It aims to evaluate three infusion doses of dexmedetomidine combined with ketamine using postoperative pain scores as the primary outcome measure. The findings may help optimize pain management protocols following cesarean section
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: ketamineDexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion |
| Medium-Dose Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: ketamineDexmedetomidine 0.3 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion |
| High-Dose Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: ketamineDexmedetomidine 0.4 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elective lower segment cesarean section
- American Society of Anesthesiologists (ASA) Physical Status II
- Provided informed consent
Key exclusion criteria (4 listed)
- Known drug allergy
- Presence of significant comorbidities
- Emergency surgery
- Documented psychiatric illness
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine infusion at one of the following doses: Group A: 0.2 µg/kg/hr Group B: 0.3 µg/kg/hr Group C: 0.4 µg/kg/hr Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period | Drug | High-Dose Dexmedetomidine, Low-Dose Dexmedetomidine, Medium-Dose Dexmedetomidine |
| ketamineKetamine infusion at a fixed dose of 0.25 mg/kg/hr administered in all three groups. Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period | Drug | High-Dose Dexmedetomidine, Low-Dose Dexmedetomidine, Medium-Dose Dexmedetomidine |
Primary outcome
Mean Postoperative Pain Score (Visual Analog Scale)
Time frame: 0-24 hours post-surgery
Pain will be assessed using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain. Visual Analog Scale (VAS) scores will be recorded at 0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.
2 secondary outcomes
Time to First Rescue Analgesia
Time frame: Continuous monitoring up to 24 hours postoperative
Total dose of rescue analgesia (Nalbuphine) required within 24 hours
Time frame: 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes. VAS scores, rescue drug doses, vitals (de-identified)
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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.
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 Dexmedetomidine and ketamine in people with Postoperative Pain and Cesarean Section Pain, run by Fatima Memorial Hospital at 1 site in Pakistan.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Naeem, MBBS (+923114681512, 2505.ahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Postoperative Pain Score (Visual Analog Scale) (time frame: 0-24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.