Pain, PostoperativeCEBNCT05581940
Pediatric Caudal Anesthesia Block. And Pain Control
An observational study of Pain, Postoperative and Adverse Reaction to Epidural Anesthesia, run by Salmaniya Medical Complex at 1 site in Bahrain.
Trial summary
Caudal epidural block CEB is the most commonly performed neuraxial block to provide effective pain relief and analgesia in patients undergoing infra-umbilical pediatric surgery. This study aimed to compare the effectiveness of adding CEB to general anesthesia in terms of intra- and post-operative pain management. Read more about this study
- Who is it for?
- Ages 3 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Adverse Reaction to Epidural Anesthesia, Anesthesia, Caudal
- What is being tested?
- Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenors
- How many people
- 72 participants
- Where
- 1 siteBahrain
- Study dates
- 5 Jan 2020to 19 Jul 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 3 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: CONsolidated Standards of Reporting Trials (CONSORT) checklist was used for enrolment and allocation of patients. Children aged between two months and six years who were undergoing infra-umbilical surgeries with ASA PS I were randomly allocated to either group A (GA with CEB) or to group B (GA without CEB).,
Who may be able to join
- Children aged between two months and six years
- who were undergoing infra-umbilical surgeries
- ASA PS I no any medical issues
Who cannot join
- CEB such as sacral anomaly
- bleeding diathesis, patients with neuromuscular disease,
- hemodynamically unstable were excluded from the study.
- Simple randomization was done to select patients who will receive CEB from the daily surgical list. This trial was not blinded.
- In terms of the sample size determination, for a study power of 80% and a probability of type I error of 5%, a total of 74 patients was required for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Caudal Anesthesia Block on Perioperative Pain Control and Reduction of the Anesthetic Agent in Pediatric Infra-umbilical Surgery: A Prospective Randomized Trial Study
Caudal epidural block CEB is the most commonly performed neuraxial block to provide effective pain relief and analgesia in patients undergoing infra-umbilical pediatric surgery. This study aimed to compare the effectiveness of adding CEB to general anesthesia in terms of intra- and post-operative pain management. Design: Double-unblinded.
Prospective. randomized. Study, Setting: salmanyia medical complex. intraoperative, postoperative recovery room Methods: A total of 72 patients American Society of Anesthesiology physical status classification ASA 1. Patients were equally allocated into two groups Group A and with CEB and Group B without CEB, aged two months to six years. respectively, over a study period of six months. Both groups were compared based on hemodynamic stability, level of sedation, analgesia need, pain score, and parental satisfaction. Postoperative pain was evaluated by four different pain scales.
Read the detailed description
the data collection uses a combination of quantitative and qualitative data. Quantitative Data: These include numerical datasets, which can be analyzed with mathematical techniques and are collected based on scales such as numbers of patients with or without CEB, interval, ratio, and ordinal. Resultantly, then the data are surveys and questionnaires, observations of hemodynamics, and behaviors. and data pain scores are collected inside the recovery room and based on the Children's Hospital Eastern Ontario Pain Scale (CHEOPS), Faces Pain Scale-Revised (FPS-R), and Face, Legs, Activity, Cry CONSOL ability (FLACC) scales. That data was collected through four phases, pre-op Intra op and post-op 1 hour in PACU, and six hours post-op was observed by the nurses in the ward. the data is divided into primary and secondary. the primary data were directly collected from the parents and information on the medical history from the files in the hospital was recorded, and the secondary data was collected directly by the anesthesiologist inside the operation room Once the patient was shifted to the operating theatre, the patient's age, sex, weight, height, types of surgeries will be performed, and the type of GA induction and maintenance agents were recorded in the anesthesia charts then in the recovery room, patients, pain scores, and behaviors are monitored according to the regular in the organization, then in the ward are based on questionnaires, observations and comparing the statically significant value between the two groups. The raw data which was collected from case report forms were entered into a Microsoft Excel Spreadsheet initially. Then, the data have been transferred to and analyzed by IBM SPSS Statistics software version 21. The categorical and numerical variables of both groups were analyzed and compared. Data are expressed as n (%), mean ± standard deviation or median and interquartile range (IQR) according to distribution normality. Continuous variables were compared using the Mann-Whitney U test, and categorical variables were compared using Fisher's exact test or Pearson Chi-square test. The confidence interval was set at 95%.
- Being tested
- Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenors
- Keywords
- caudal, Pain Management, Anesthesia, pediatric
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenorsCombination product
Also called Regional anesthesia intervention and pain control
(CEB) in group A using drugs bupivacaine 0.25% commonly used in children including neonates in group A In infraumbilical operations, it is used as a supplement to GA and to control postoperative pain It is a safe, easy, and effective type of central neuraxial block.[ The patient will be intubated and the caudal block will be performed under GA after securing the airway. The patient's position will be turned onto the lateral decubitus then a landmark-based, blind technique will be used. In children, the success rate with the blind technique is above 96% but the occurrence of side effects is reported. Group B uses general anesthesia (GA) alone for intraoperative and perioperative pain control used the opioid intervious without caudal block .
| Study group | Role | What they receive |
|---|---|---|
| Pediatric caudal anesthesia block. | caudal epidural block is a neuraxial block to provide effective pain relief and analgesia in pediatrics undergoing infra-umbilical pediatric surgery this study aimed to compare the effectiveness of adding to general anesthesia in terms of Intra and post-op pain management. A prospective, randomized case-controlled.A total of 72 patients aged two months to six years with (ASA PS) I (ASA I) were recruited over a six-month period between December 2019 and May 2020. Patients were allocated into two groups A performed under general anesthesia with caudal block and group B performed under general anesthesia alone. Both groups were compared based on hemodynamic stability, analgesia need, pain score, and parental satisfaction. Postoperative pain was evaluated by the Pain Scale- Categorical and numerical variables of both groups were compared. Results: Receives: Combination Product: Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenors |
What is being measured
The primary outcome is the main question the study is designed to answer.
demographic data in two groups recorded and compared intra operation room.
the patient's in two groups .The demographic data for all patients as age\months, sex\female ,male, weight( kilogram ,Height\centimeter were recorded in the anesthesia chart.
Measured: Demographic data of children in both groups. Recorded through study completion, an average of 1 year".
hemodynamics changed in Bothe groups intra op and one hour and six hours post op
the Baseline Systolic and diastolic Blood Pressure pre operation and intraoperation and 60 minuet post operation have been recorded in group A and group B..
Measured: through study completion, an average of 1 year". Measures of change in bassline of hemodynamic stability in both groups A and B Period preop and interop and post operation the data are presented as mean ± standard deviation .
pain scores and sedation degree of children through one and six hours post operation in both groups
pain scores at the various time points, and postoperative analgesia Based on the Face, Legs, Activity, Cry, consolability (FLACC) scale is a measurement used to assess pain for children between the age of 2 month and 7 years or individuals that are unable to communicate their pain .the scale is scored range from 0 to 10 with 0 is presenting no paint the scale has five criteria witch are each assigned a score of 0,1 or ,2,
Measured: through study completion, an average of 1 year Continuous variables were compared period one hour and 6 hours post op using Mann-Whitney U.df=degree of freedom,
Secondary outcomes (1)
Differences in CHEOPS Score (4-13) d\through one hour and six hours post operation. between group A and B
All Children have been observed by nurses and anesthesiologists in post anesthesia care unit using the children s Hospital Estern Ontario Pain ScaleCHEOPS is a behaviors pain scale in young children for evaluating postoperative pain it used to monitor the effectiveness of interventions for reducing the pain and discomfort .CHEOPS pain score is sum points for the all 6 parameters cry. facial. touch. legs. child verbal. Torso. the score ranging from 4 to 13 where is considered above 5 presented of pain .and the score recorded at the 30 minutes .and 60 minutes add to 6 hours post operation. Using Mann-Whitney U test and categorical variables were compared using *Fisher's exact test or †Pearson Chi-square test. P value is considered statistically significant and, degree of freedom, confidence interval
Measured: through study completion, an average of 1 year pain scale that is used to assist the pain in children in bout groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start5 Jan 2020
- Primary completion10 Jul 2020
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Salmaniya Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeana gawe, Salmaniya Medical Complex
- Investigators
- Zeana Gawe, specialist, Principal investigator, salmanyia medical complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581940
- Sponsor's protocol ID
- 123311219
- Acronym
- CEB
- Status last verified
- Oct 2022
- First submitted
- 31 Jul 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: the research data is intended for this research only and not to share in another research .and data were analyzed according to the protocol
Publications
Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.
PubMed 25393589Banerjee A, Das B, Mukherjee D, Khanra M. A study of the effect of caudal epidural block on bispectral index targeted propofol requirement in children: A comparative study. J Indian Assoc Pediatr Surg. 2015 Apr-Jun;20(2):77-81. doi: 10.4103/0971-9261.151551.
PubMed 25829671Shamim F, Ullah H, Khan FA. Postoperative pain assessment using four behavioral scales in Pakistani children undergoing elective surgery. Saudi J Anaesth. 2015 Apr-Jun;9(2):174-8. doi: 10.4103/1658-354X.152874.
PubMed 25829906Senoglu N, Senoglu M, Oksuz H, Gumusalan Y, Yuksel KZ, Zencirci B, Ezberci M, Kizilkanat E. Landmarks of the sacral hiatus for caudal epidural block: an anatomical study. Br J Anaesth. 2005 Nov;95(5):692-5. doi: 10.1093/bja/aei236. Epub 2005 Sep 9.
PubMed 16155035Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.
PubMed 28337460Ozen V, Yigit D. A comparison of the postoperative analgesic effectiveness of low dose caudal epidural block and US-guided dorsal penile nerve block with in-plane technique in circumcision. J Pediatr Urol. 2020 Feb;16(1):99-106. doi: 10.1016/j.jpurol.2019.10.020. Epub 2019 Oct 30.
PubMed 31759904Nikooseresht M, Hashemi M, Mohajerani SA, Shahandeh F, Agah M. Ultrasound as a screening tool for performing caudal epidural injections. Iran J Radiol. 2014 May;11(2):e13262. doi: 10.5812/iranjradiol.13262. Epub 2014 May 15.
PubMed 25035698Kim YH, Park HJ, Cho S, Moon DE. Assessment of factors affecting the difficulty of caudal epidural injections in adults using ultrasound. Pain Res Manag. 2014 Sep-Oct;19(5):275-9. doi: 10.1155/2014/679128. Epub 2014 Aug 11.
PubMed 25111987Shin SK, Hong JY, Kim WO, Koo BN, Kim JE, Kil HK. Ultrasound evaluation of the sacral area and comparison of sacral interspinous and hiatal approach for caudal block in children. Anesthesiology. 2009 Nov;111(5):1135-40. doi: 10.1097/ALN.0b013e3181bc6dd4.
PubMed 19809281Ben-David B, Vaida S, Gaitini L. The influence of high spinal anesthesia on sensitivity to midazolam sedation. Anesth Analg. 1995 Sep;81(3):525-8. doi: 10.1097/00000539-199509000-00017.
PubMed 7653816Joo J, Kim J, Lee J. The prevalence of anatomical variations that can cause inadvertent dural puncture when performing caudal block in Koreans: a study using magnetic resonance imaging. Anaesthesia. 2010 Jan;65(1):23-6. doi: 10.1111/j.1365-2044.2009.06168.x. Epub 2009 Nov 17.
PubMed 19922508Manchikanti L, Cash KA, Pampati V, McManus CD, Damron KS. Evaluation of fluoroscopically guided caudal epidural injections. Pain Physician. 2004 Jan;7(1):81-92.
PubMed 16868617Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.
PubMed 11427329
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caudal Anesthesia Block on Perioperative Pain Control and Reduction of the Anesthetic Agent in Pediatric Infra-umbilical Surgery: A Prospective Randomized Trial Study
- ClinicalTrials.gov ID
- NCT05581940
- Acronym / sponsor ID
- CEB / 123311219
- Keywords
- caudal, Pain Management, Anesthesia, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Salmaniya Medical ComplexOther government
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 17 Oct 2022 (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.
Caudal epidural block CEB is the most commonly performed neuraxial block to provide effective pain relief and analgesia in patients undergoing infra-umbilical pediatric surgery. This study aimed to compare the effectiveness of adding CEB to general anesthesia in terms of intra- and post-operative pain management. Design: Double-unblinded.
Prospective. randomized. Study, Setting: salmanyia medical complex. intraoperative, postoperative recovery room Methods: A total of 72 patients American Society of Anesthesiology physical status classification ASA 1. Patients were equally allocated into two groups Group A and with CEB and Group B without CEB, aged two months to six years. respectively, over a study period of six months. Both groups were compared based on hemodynamic stability, level of sedation, analgesia need, pain score, and parental satisfaction. Postoperative pain was evaluated by four different pain scales.
Detailed description
the data collection uses a combination of quantitative and qualitative data. Quantitative Data: These include numerical datasets, which can be analyzed with mathematical techniques and are collected based on scales such as numbers of patients with or without CEB, interval, ratio, and ordinal. Resultantly, then the data are surveys and questionnaires, observations of hemodynamics, and behaviors. and data pain scores are collected inside the recovery room and based on the Children's Hospital Eastern Ontario Pain Scale (CHEOPS), Faces Pain Scale-Revised (FPS-R), and Face, Legs, Activity, Cry CONSOL ability (FLACC) scales. That data was collected through four phases, pre-op Intra op and post-op 1 hour in PACU, and six hours post-op was observed by the nurses in the ward. the data is divided into primary and secondary. the primary data were directly collected from the parents and information on the medical history from the files in the hospital was recorded, and the secondary data was collected directly by the anesthesiologist inside the operation room Once the patient was shifted to the operating theatre, the patient's age, sex, weight, height, types of surgeries will be performed, and the type of GA induction and maintenance agents were recorded in the anesthesia charts then in the recovery room, patients, pain scores, and behaviors are monitored according to the regular in the organization, then in the ward are based on questionnaires, observations and comparing the statically significant value between the two groups. The raw data which was collected from case report forms were entered into a Microsoft Excel Spreadsheet initially. Then, the data have been transferred to and analyzed by IBM SPSS Statistics software version 21. The categorical and numerical variables of both groups were analyzed and compared. Data are expressed as n (%), mean ± standard deviation or median and interquartile range (IQR) according to distribution normality. Continuous variables were compared using the Mann-Whitney U test, and categorical variables were compared using Fisher's exact test or Pearson Chi-square test. The confidence interval was set at 95%.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric caudal anesthesia block. | – | Combination Product: Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenorscaudal epidural block is a neuraxial block to provide effective pain relief and analgesia in pediatrics undergoing infra-umbilical pediatric surgery this study aimed to compare the effectiveness of adding to general anesthesia in terms of Intra and post-op pain management. A prospective, randomized case-controlled.A total of 72 patients aged two months to six years with (ASA PS) I (ASA I) were recruited over a six-month period between December 2019 and May 2020. Patients were allocated into two groups A performed under general anesthesia with caudal block and group B performed under general anesthesia alone. Both groups were compared based on hemodynamic stability, analgesia need, pain score, and parental satisfaction. Postoperative pain was evaluated by the Pain Scale- Categorical and numerical variables of both groups were compared. Results: |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- CONsolidated Standards of Reporting Trials (CONSORT) checklist was used for enrolment and allocation of patients. Children aged between two months and six years who were undergoing infra-umbilical surgeries with ASA PS I were randomly allocated to either group A (GA with CEB) or to group B (GA without CEB).,
Key inclusion criteria (3 listed)
- Children aged between two months and six years
- who were undergoing infra-umbilical surgeries
- ASA PS I no any medical issues
Key exclusion criteria (5 listed)
- CEB such as sacral anomaly
- bleeding diathesis, patients with neuromuscular disease,
- hemodynamically unstable were excluded from the study.
- Simple randomization was done to select patients who will receive CEB from the daily surgical list. This trial was not blinded.
- In terms of the sample size determination, for a study power of 80% and a probability of type I error of 5%, a total of 74 patients was required for the study.
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 |
|---|---|---|
| Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenorsAlso: Regional anesthesia intervention and pain control(CEB) in group A using drugs bupivacaine 0.25% commonly used in children including neonates in group A In infraumbilical operations, it is used as a supplement to GA and to control postoperative pain It is a safe, easy, and effective type of central neuraxial block.[ The patient will be intubated and the caudal block will be performed under GA after securing the airway. The patient's position will be turned onto the lateral decubitus then a landmark-based, blind technique will be used. In children, the success rate with the blind technique is above 96% but the occurrence of side effects is reported. Group B uses general anesthesia (GA) alone for intraoperative and perioperative pain control used the opioid intervious without caudal block . | Combination product | Pediatric caudal anesthesia block. |
Primary outcome
demographic data in two groups recorded and compared intra operation room.
Time frame: Demographic data of children in both groups. Recorded through study completion, an average of 1 year".
the patient's in two groups .The demographic data for all patients as age\months, sex\female ,male, weight( kilogram ,Height\centimeter were recorded in the anesthesia chart.
hemodynamics changed in Bothe groups intra op and one hour and six hours post op
Time frame: through study completion, an average of 1 year". Measures of change in bassline of hemodynamic stability in both groups A and B Period preop and interop and post operation the data are presented as mean ± standard deviation .
the Baseline Systolic and diastolic Blood Pressure pre operation and intraoperation and 60 minuet post operation have been recorded in group A and group B..
pain scores and sedation degree of children through one and six hours post operation in both groups
Time frame: through study completion, an average of 1 year Continuous variables were compared period one hour and 6 hours post op using Mann-Whitney U.df=degree of freedom,
pain scores at the various time points, and postoperative analgesia Based on the Face, Legs, Activity, Cry, consolability (FLACC) scale is a measurement used to assess pain for children between the age of 2 month and 7 years or individuals that are unable to communicate their pain .the scale is scored range from 0 to 10 with 0 is presenting no paint the scale has five criteria witch are each assigned a score of 0,1 or ,2,
1 secondary outcome
Differences in CHEOPS Score (4-13) d\through one hour and six hours post operation. between group A and B
Time frame: through study completion, an average of 1 year pain scale that is used to assist the pain in children in bout groups.
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 17 Oct 2022.
- Background: PubMed 25393589Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.
- Results publication: PubMed 25829671Banerjee A, Das B, Mukherjee D, Khanra M. A study of the effect of caudal epidural block on bispectral index targeted propofol requirement in children: A comparative study. J Indian Assoc Pediatr Surg. 2015 Apr-Jun;20(2):77-81. doi: 10.4103/0971-9261.151551.
- Results publication: PubMed 25829906Shamim F, Ullah H, Khan FA. Postoperative pain assessment using four behavioral scales in Pakistani children undergoing elective surgery. Saudi J Anaesth. 2015 Apr-Jun;9(2):174-8. doi: 10.4103/1658-354X.152874.
- Results publication: PubMed 16155035Senoglu N, Senoglu M, Oksuz H, Gumusalan Y, Yuksel KZ, Zencirci B, Ezberci M, Kizilkanat E. Landmarks of the sacral hiatus for caudal epidural block: an anatomical study. Br J Anaesth. 2005 Nov;95(5):692-5. doi: 10.1093/bja/aei236. Epub 2005 Sep 9.
- Results publication: PubMed 28337460Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.
- Results publication: PubMed 31759904Ozen V, Yigit D. A comparison of the postoperative analgesic effectiveness of low dose caudal epidural block and US-guided dorsal penile nerve block with in-plane technique in circumcision. J Pediatr Urol. 2020 Feb;16(1):99-106. doi: 10.1016/j.jpurol.2019.10.020. Epub 2019 Oct 30.
- Results publication: PubMed 25035698Nikooseresht M, Hashemi M, Mohajerani SA, Shahandeh F, Agah M. Ultrasound as a screening tool for performing caudal epidural injections. Iran J Radiol. 2014 May;11(2):e13262. doi: 10.5812/iranjradiol.13262. Epub 2014 May 15.
- Results publication: PubMed 25111987Kim YH, Park HJ, Cho S, Moon DE. Assessment of factors affecting the difficulty of caudal epidural injections in adults using ultrasound. Pain Res Manag. 2014 Sep-Oct;19(5):275-9. doi: 10.1155/2014/679128. Epub 2014 Aug 11.
- Results publication: PubMed 19809281Shin SK, Hong JY, Kim WO, Koo BN, Kim JE, Kil HK. Ultrasound evaluation of the sacral area and comparison of sacral interspinous and hiatal approach for caudal block in children. Anesthesiology. 2009 Nov;111(5):1135-40. doi: 10.1097/ALN.0b013e3181bc6dd4.
- Results publication: PubMed 7653816Ben-David B, Vaida S, Gaitini L. The influence of high spinal anesthesia on sensitivity to midazolam sedation. Anesth Analg. 1995 Sep;81(3):525-8. doi: 10.1097/00000539-199509000-00017.
- Results publication: PubMed 19922508Joo J, Kim J, Lee J. The prevalence of anatomical variations that can cause inadvertent dural puncture when performing caudal block in Koreans: a study using magnetic resonance imaging. Anaesthesia. 2010 Jan;65(1):23-6. doi: 10.1111/j.1365-2044.2009.06168.x. Epub 2009 Nov 17.
- Results publication: PubMed 16868617Manchikanti L, Cash KA, Pampati V, McManus CD, Damron KS. Evaluation of fluoroscopically guided caudal epidural injections. Pain Physician. 2004 Jan;7(1):81-92.
- Individual participant dataSharing planned: No. the research data is intended for this research only and not to share in another research .and data were analyzed according to the protocol
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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. This study is not recruiting at the moment.
Zeana Gawe, specialist principal investigator
salmanyia medical complex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Adverse Reaction to Epidural Anesthesia, run by Salmaniya Medical Complex at 1 site in Bahrain.
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 5 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 17 Oct 2022. 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 Bahrain. 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.
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?
demographic data in two groups recorded and compared intra operation room. (time frame: Demographic data of children in both groups. Recorded through study completion, an average of 1 year".). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05581940, which also lists 13 linked publications.
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 17 Oct 2022.