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Trial record 71 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

Effect of Intravenous Paracetamol in Combination With Caudal Ropivacaine on Quality of Postoperative Recovery in Paediatric Patients Undergoing Hypospadias Repair

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ClinicalTrials.gov Identifier: NCT03781505
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Muhammad Saad Yousuf, Aga Khan University

Brief Summary:
To investigate whether the addition of intravenous paracetamol with caudal ropivacaine leads to better quality of postoperative recovery in patients undergoing hypospadius repair than caudal ropivacaine alone. The quality of recovery will be judged by postoperative analgesia requirement and lesser agitation in the postoperative period.

Condition or disease Intervention/treatment Phase
Postoperative Analgesia Drug: Paracetamol +caudal ropivacaine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trail
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Paracetamol in Combination With Caudal Ropivacaine on Quality of Postoperative Recovery in Paediatric Patients Undergoing Hypospadias Repair
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous paracetamol with Caudal Ropivacaine

Paracetamol is widely accepted and most commonly used as an adjuvant for postoperative analgesia. It also improves the quality of recovery by attenuating the pain associated with the surgical position. Adverse effects associated with the paracetamol are rare <1/10000, which includes malaise, increased level of hepatic transaminases and hypersensitivity reaction. It has been studied in combination with caudal analgesia with bupivacaine through the rectal route 7,8 with variable results.

Caudal anaesthesia is effective in alleviating pain below the umbilicus. Also if the caudal block is administered at the beginning of surgery, the effect will start wearing off 2 to 3 hours post surgery. Administration of paracetamol towards end of surgery may help with both these issues. In this study we aim to investigate the effect of adding intravenous paracetamol in combination with caudal analgesia with ropivacaine, hoping that it may improve quality of postoperative analgesia and recovery.

Drug: Paracetamol +caudal ropivacaine
Paracetamol + Ropivacaine

Placebo Comparator: Placebo
Intravenous Normal Saline with Caudal Ropivacaine
Drug: Paracetamol +caudal ropivacaine
Paracetamol + Ropivacaine




Primary Outcome Measures :
  1. Postoperative analgesia requirement [ Time Frame: follow till 6 hours postoperatively ]
    Time to the first analgesic requirement will be calculated as the time from the performance of caudal block to the first analgesic dose administered. This time will be noted in minutes.

  2. Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) Assessement for Postoperative Pain [ Time Frame: follow till 6 hours postoperatively ]
    The requirement of postoperative analgesia of the patient will be evaluated by using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). This scale has 5 domains. It includes crying, facial expression, verbal response, touching the wound and torso and leg movement. It is a behavioural scale and measures each domain on a numerical scale of 0 to 2. Minimum score is 0 while maximum score is 10. Aggregate score will be added. Score less than 4 will be consider adequate analgesia while score greater than 4 will be consider inadequate analgesia. This score is just a numerical number with no other value attached to it.


Secondary Outcome Measures :
  1. Sedation [ Time Frame: follow till 6 hours postoperatively ]

    Sedation will be assessed by using Pasero Opioid-Induced Sedation Scale (POSS). This scale measures sedation on numerical score of 0 to 4. Minimum score is 0 while maximum score is 4.

    It comprises of; 0: awake; 1: mild sedation; 2: sleeping, but able to wake; 3: Frequently drowsy, arousable, drifts off to sleep during conversation, unable to wake and 4: Somnolent, minimal or no response to verbal or physical stimulation.

    A POSS score of 0, 1, or 2 indicates an acceptable level of sedation, whereas a score of 3 or 4 indicates over-sedation and the need for a reversal agent. This score is just a numerical number with no other value attached to it.




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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 3-10 years
  2. ASA I and II
  3. Undergoing hypospadias repair surgery

Exclusion Criteria:

  1. Coagulopathy
  2. Aspirin or any other analgesic ingestion in the preceding week
  3. Preexisting neurological or spinal disease
  4. Hepatic, renal disease and malnutrition
  5. Severe hypovolemia
  6. Uncontrolled convulsions
  7. Refusal of the parents
  8. Local Skin infection at the puncture site
  9. Allergy to local anesthetics
  10. Patient previously involved in other studies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781505


Contacts
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Contact: Muhammad S Yousuf, FCPS 9221+3003540362 ext 4637 saad.yousuf@aku.edu
Contact: Fauzia A Khan, FRCA fauzia.khan@aku.edu

Locations
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Pakistan
Aga Khan University Hospital Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Muhammad S Yousuf, FCPS    00923003540362    saad.yousuf@aku.edu   
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Muhammad S Yousuf, FCPS Aga Khan University

Publications:
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Responsible Party: Dr. Muhammad Saad Yousuf, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT03781505     History of Changes
Other Study ID Numbers: 5445-Ane-ERC-18
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Ropivacaine
Acetaminophen
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Antipyretics