Clinical trial NCT05581940: Pediatric Caudal Anesthesia Block. And Pain Control
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Adverse Reaction to Epidural Anesthesia
Anesthesia, Caudal
Keywords: caudal
Pain Management
Anesthesia
pediatric
Lead sponsor: Salmaniya Medical Complex
Sponsor class: OTHER_GOV
First posted: 2022-10-17
Enrollment: 72
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).,

Brief 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. 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%.

Eligibility criteria: Inclusion Criteria:

* Children aged between two months and six years
* who were undergoing infra-umbilical surgeries
* ASA PS I no any medical issues

Exclusion Criteria:

* 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.

Primary outcomes:
measure: demographic data in two groups recorded and compared intra operation room.
timeFrame: Demographic data of children in both groups. Recorded through study completion, an average of 1 year".
measure: hemodynamics changed in Bothe groups intra op and one hour and six hours post op
timeFrame: 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 .
measure: pain scores and sedation degree of children through one and six hours post operation in both groups
timeFrame: 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:
measure: Differences in CHEOPS Score (4-13) d\through one hour and six hours post operation. between group A and B
timeFrame: through study completion, an average of 1 year pain scale that is used to assist the pain in children in bout groups.
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: Salmanyia Medical Complex
Study officials:
affiliation: salmanyia medical complex
name: Zeana Gawe, specialist
role: PRINCIPAL_INVESTIGATOR
References:
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