Post Spinal ShiveringPhase 2NCT07784556
THIS STUDY AIMS TO COMPARE TWO DRUGS KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING SPINAL ANESTHESIA STUDY POPULATION IS PT UNDERGOING C SECTION . DOSE OF KETAMINE IS 0.25mg/kg and That of TRAMAL 0.5mg/kg.
A Phase 2 study testing Tramadol and Ketamine (0.25 mg/kg) in people with Post Spinal Shivering, run by KRL Hospital, Islamabad at 2 sites in Pakistan.
Trial summary
This randomized controlled clinical trial compared the efficacy of intravenous ketamine and tramadol in preventing post-spinal anaesthesia shivering among women undergoing elective caesarean section under spinal anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Spinal Shivering
- What is being tested?
- Tramadol and Ketamine (0.25 mg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Jul 2024to 21 Sep 2025
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA-2 and ASA-3 patients Undergoing Elective C-Section
Who cannot join
- ASA-4 and above Emergency C-Section Cases
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
KRL hospital islamabad
Islamabad, Islamabad, 44000
KRL hospital islamabad
Rawalpindi, Punjab Province, 46000
About this study
Official title: COMPARISON BETWEEN KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING C SECTION UNDER SPINAL ANESTHESIA
This randomized controlled clinical trial compared the efficacy of intravenous ketamine and tramadol in preventing post-spinal anaesthesia shivering among women undergoing elective caesarean section under spinal anaesthesia. Seventy pregnant women aged 18-45 years with ASA physical status II or III were enrolled and randomly assigned to receive either intravenous tramadol (0.5 mg/kg) or intravenous ketamine (0.25 mg/kg) immediately after delivery of the baby. The primary outcome was the prevention of shivering, defined as the absence of shivering throughout the intraoperative period using the bedside shivering assessment score. Secondary outcomes included the onset time of shivering and comparison of efficacy according to age, body mass index (BMI), and ASA physical status. The study found that ketamine was significantly more effective than tramadol in preventing post-spinal anaesthesia shivering in women undergoing caesarean section, with a lower incidence of shivering and higher overall efficacy. These findings suggest that prophylactic low-dose ketamine may be a more effective option than tramadol for reducing spinal anaesthesia-related shivering during caesarean delivery
Read the detailed description
This randomized controlled clinical trial was conducted at Khan Research Laboratory Hospital, Islamabad, from August 2024 to January 2025 after obtaining ethical approval. The objective was to compare the efficacy of intravenous ketamine and intravenous tramadol in preventing shivering among women undergoing elective caesarean section under spinal anaesthesia.
A total of 70 pregnant women aged between 18 and 45 years with ASA physical status II or III and a body mass index between 18 and 35 kg/m² were included after obtaining written informed consent. Patients with contraindications to spinal anaesthesia, significant medical comorbidities, allergy to study drugs, obstetric emergencies, pre-existing bradycardia, hypotension, or refusal to undergo spinal anaesthesia were excluded.
Participants were randomly allocated into two equal groups using a coin-flip randomization method. Standard perioperative preparation and monitoring were performed for all patients. Spinal anaesthesia was administered using hyperbaric bupivacaine through a standard spinal technique. Immediately after delivery of the baby, patients received either intravenous tramadol (0.5 mg/kg) or intravenous ketamine (0.25 mg/kg) according to their assigned study group.
Patients were monitored throughout surgery for the occurrence of shivering using the bedside shivering assessment score. The primary endpoint was efficacy, defined as complete absence of shivering until completion of surgery and wound closure. Secondary outcome measures included the incidence of shivering, onset time of shivering after spinal anaesthesia, and subgroup analyses according to age, BMI, and ASA physical status.
Data were analysed using SPSS version 30. Quantitative variables were summarized using median and interquartile range because data were not normally distributed. Qualitative variables were expressed as frequencies and percentages. Group comparisons were performed using the Chi-square test, Fisher's exact test, and Mann-Whitney U test where appropriate. A p-value of ≤0.05 was considered statistically significant.
The baseline demographic characteristics were comparable between the two groups with respect to age, BMI, and ASA status. The incidence of post-spinal anaesthesia shivering was significantly lower in the ketamine group than in the tramadol group. Patients receiving ketamine demonstrated a substantially higher proportion of successful prevention of shivering compared with those receiving tramadol. Furthermore, the onset of shivering was delayed or absent in most patients receiving ketamine. Stratified analyses according to age, BMI, and ASA classification did not demonstrate any significant influence of these variables on treatment efficacy.
The study findings indicate that prophylactic low-dose intravenous ketamine provides superior protection against post-spinal anaesthesia shivering compared with low-dose intravenous tramadol in women undergoing caesarean section under spinal anaesthesia. These results support the use of ketamine as an effective prophylactic agent for reducing intraoperative shivering in obstetric patients and may contribute to improved maternal comfort.
- Conditions
- Post Spinal Shivering
- Being tested
- Tramadol, Ketamine (0.25 mg/kg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Single IV dose of tramadol 0.5 mg/kg given immediately after delivery.
Ketamine (0.25 mg/kg)Drug
Single intravenous dose of ketamine 0.25 mg/kg administered immediately after delivery of the baby during elective caesarean section under spinal anaesthesia for prevention of post-spinal shivering.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol Group | Active comparator | Participants received intravenous tramadol 0.5 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering. Receives: Drug: Tramadol |
| Ketamine Group | Experimental | Participants received intravenous ketamine 0.25 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering. Receives: Drug: Ketamine (0.25 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Spinal Anesthesia Shivering
Proportion of patients who developed shivering after spinal anesthesia, graded using the Tsai and Chu shivering scale (0 = no shivering; 1 = piloerection; 2 = visible tremors in one muscle group; 3 = visible tremors in more than one muscle group; 4 = gross tremors of the whole body).
Measured: Within 30 minutes of spinal anesthesia administration
Secondary outcomes (1)
Severity of Post-Spinal Anesthesia Shivering
Severity of shivering graded using the Tsai and Chu scale (0-4) in patients who developed shivering after spinal anesthesia.
Measured: Within 30 minutes of spinal anesthesia administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start15 Jul 2024
- Primary completion20 Aug 2025
- Study completion21 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal ShiveringStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- KRL Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hibba Asif, KRL Hospital, Islamabad
- Investigators
- Amna Raza, MBBS FCPS, Study chair, KRL Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784556
- Sponsor's protocol ID
- Compbketandtramal123
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON BETWEEN KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING C SECTION UNDER SPINAL ANESTHESIA
- ClinicalTrials.gov ID
- NCT07784556
- Acronym / sponsor ID
- Compbketandtramal123
- Conditions
- Post Spinal Shivering
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- KRL Hospital, IslamabadUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 21 Sep 2025 (actual)
- First posted
- 25 Aug 2026 (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 randomized controlled clinical trial compared the efficacy of intravenous ketamine and tramadol in preventing post-spinal anaesthesia shivering among women undergoing elective caesarean section under spinal anaesthesia. Seventy pregnant women aged 18-45 years with ASA physical status II or III were enrolled and randomly assigned to receive either intravenous tramadol (0.5 mg/kg) or intravenous ketamine (0.25 mg/kg) immediately after delivery of the baby. The primary outcome was the prevention of shivering, defined as the absence of shivering throughout the intraoperative period using the bedside shivering assessment score. Secondary outcomes included the onset time of shivering and comparison of efficacy according to age, body mass index (BMI), and ASA physical status. The study found that ketamine was significantly more effective than tramadol in preventing post-spinal anaesthesia shivering in women undergoing caesarean section, with a lower incidence of shivering and higher overall efficacy. These findings suggest that prophylactic low-dose ketamine may be a more effective option than tramadol for reducing spinal anaesthesia-related shivering during caesarean delivery
Detailed description
This randomized controlled clinical trial was conducted at Khan Research Laboratory Hospital, Islamabad, from August 2024 to January 2025 after obtaining ethical approval. The objective was to compare the efficacy of intravenous ketamine and intravenous tramadol in preventing shivering among women undergoing elective caesarean section under spinal anaesthesia.
A total of 70 pregnant women aged between 18 and 45 years with ASA physical status II or III and a body mass index between 18 and 35 kg/m² were included after obtaining written informed consent. Patients with contraindications to spinal anaesthesia, significant medical comorbidities, allergy to study drugs, obstetric emergencies, pre-existing bradycardia, hypotension, or refusal to undergo spinal anaesthesia were excluded.
Participants were randomly allocated into two equal groups using a coin-flip randomization method. Standard perioperative preparation and monitoring were performed for all patients. Spinal anaesthesia was administered using hyperbaric bupivacaine through a standard spinal technique. Immediately after delivery of the baby, patients received either intravenous tramadol (0.5 mg/kg) or intravenous ketamine (0.25 mg/kg) according to their assigned study group.
Patients were monitored throughout surgery for the occurrence of shivering using the bedside shivering assessment score. The primary endpoint was efficacy, defined as complete absence of shivering until completion of surgery and wound closure. Secondary outcome measures included the incidence of shivering, onset time of shivering after spinal anaesthesia, and subgroup analyses according to age, BMI, and ASA physical status.
Data were analysed using SPSS version 30. Quantitative variables were summarized using median and interquartile range because data were not normally distributed. Qualitative variables were expressed as frequencies and percentages. Group comparisons were performed using the Chi-square test, Fisher's exact test, and Mann-Whitney U test where appropriate. A p-value of ≤0.05 was considered statistically significant.
The baseline demographic characteristics were comparable between the two groups with respect to age, BMI, and ASA status. The incidence of post-spinal anaesthesia shivering was significantly lower in the ketamine group than in the tramadol group. Patients receiving ketamine demonstrated a substantially higher proportion of successful prevention of shivering compared with those receiving tramadol. Furthermore, the onset of shivering was delayed or absent in most patients receiving ketamine. Stratified analyses according to age, BMI, and ASA classification did not demonstrate any significant influence of these variables on treatment efficacy.
The study findings indicate that prophylactic low-dose intravenous ketamine provides superior protection against post-spinal anaesthesia shivering compared with low-dose intravenous tramadol in women undergoing caesarean section under spinal anaesthesia. These results support the use of ketamine as an effective prophylactic agent for reducing intraoperative shivering in obstetric patients and may contribute to improved maternal comfort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Tramadol Group | Active comparator | Drug: TramadolParticipants received intravenous tramadol 0.5 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering. |
| Ketamine Group | Experimental | Drug: Ketamine (0.25 mg/kg)Participants received intravenous ketamine 0.25 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA-2 and ASA-3 patients Undergoing Elective C-Section
Key exclusion criteria (1 listed)
- ASA-4 and above Emergency C-Section Cases
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 |
|---|---|---|
| TramadolSingle IV dose of tramadol 0.5 mg/kg given immediately after delivery. | Drug | Tramadol Group |
| Ketamine (0.25 mg/kg)Single intravenous dose of ketamine 0.25 mg/kg administered immediately after delivery of the baby during elective caesarean section under spinal anaesthesia for prevention of post-spinal shivering. | Drug | Ketamine Group |
Primary outcome
Incidence of Post-Spinal Anesthesia Shivering
Time frame: Within 30 minutes of spinal anesthesia administration
Proportion of patients who developed shivering after spinal anesthesia, graded using the Tsai and Chu shivering scale (0 = no shivering; 1 = piloerection; 2 = visible tremors in one muscle group; 3 = visible tremors in more than one muscle group; 4 = gross tremors of the whole body).
1 secondary outcome
Severity of Post-Spinal Anesthesia Shivering
Time frame: Within 30 minutes of spinal anesthesia administration
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 25 Aug 2026.
- Post spinal anesthesia shiveringLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly.
Related trials for Post Spinal Shivering
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Shivering, Postoperative Shivering
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Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section
Shivering, Post-Spinal Shivering
Not yet recruitingPhase 4
Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section
Shivering, Post-Spinal Shivering
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.
Amna Raza, MBBS FCPS study chair
KRL Hospital, Islamabad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tramadol and Ketamine (0.25 mg/kg) in people with Post Spinal Shivering, run by KRL Hospital, Islamabad at 2 sites 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 1 inclusion and 1 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of Post-Spinal Anesthesia Shivering (time frame: Within 30 minutes of spinal anesthesia administration). 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 25 Aug 2026.