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Dexamethasone & Ketamine as Adjuvants to Bupivacaine for Incisional Infiltration in Pediatric Abdominal Operations

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ClinicalTrials.gov Identifier: NCT05190952
Recruitment Status : Completed
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Diaaeldein Mahmoud Haiba, Ain Shams University

Tracking Information
First Submitted Date  ICMJE December 29, 2021
First Posted Date  ICMJE January 13, 2022
Last Update Posted Date January 13, 2022
Actual Study Start Date  ICMJE December 5, 2020
Actual Primary Completion Date March 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2021)
  • The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale [ Time Frame: At Time zero (The time of extubation) ]
    -Face: No particular expression or smile (0) Occasional grimace or frown, withdrawn, disinterested (1) Frequent to constant frown, clenched jaw, quivering chin (2) -Legs: Normal position or relaxed (0) Uneasy, restless, tense (1) Kicking, legs drawn up (2) -Activity: Lying quietly, normal position, moves easily (0) Squirming, shifting back and forth, tense (1) Arched, rigid or jerking (2) -Cry: No crying (awake or asleep) (0) Moans or whimpers, occasional complaint (1) Crying steadily, screamsor sobs, frequent complaints (2) -Consolability: Content, relaxed (0) Reassured by occasional touching, hugging or talking to, distractable (1) Difficult to console or comfort (2) The scale range from 0 to 10. The higher the number the worse the pain status.
  • The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale [ Time Frame: At 2 hours postoperatively ]
    -Face: No particular expression or smile (0) Occasional grimace or frown, withdrawn, disinterested (1) Frequent to constant frown, clenched jaw, quivering chin (2) -Legs: Normal position or relaxed (0) Uneasy, restless, tense (1) Kicking, legs drawn up (2) -Activity: Lying quietly, normal position, moves easily (0) Squirming, shifting back and forth, tense (1) Arched, rigid or jerking (2) -Cry: No crying (awake or asleep) (0) Moans or whimpers, occasional complaint (1) Crying steadily, screamsor sobs, frequent complaints (2) -Consolability: Content, relaxed (0) Reassured by occasional touching, hugging or talking to, distractable (1) Difficult to console or comfort (2) The scale range from 0 to 10. The higher the number the worse the pain status.
  • The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale [ Time Frame: At 12 hours postoperatively ]
    Face: No particular expression or smile (0) Occasional grimace or frown, withdrawn, disinterested (1) Frequent to constant frown, clenched jaw, quivering chin (2) -Legs: Normal position or relaxed (0) Uneasy, restless, tense (1) Kicking, legs drawn up (2) -Activity: Lying quietly, normal position, moves easily (0) Squirming, shifting back and forth, tense (1) Arched, rigid or jerking (2) -Cry: No crying (awake or asleep) (0) Moans or whimpers, occasional complaint (1) Crying steadily, screamsor sobs, frequent complaints (2) -Consolability: Content, relaxed (0) Reassured by occasional touching, hugging or talking to, distractable (1) Difficult to console or comfort (2) The scale range from 0 to 10. The higher the number the worse the pain status.
  • The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale [ Time Frame: At 24 hours postoperatively ]
    Face: No particular expression or smile (0) Occasional grimace or frown, withdrawn, disinterested (1) Frequent to constant frown, clenched jaw, quivering chin (2) -Legs: Normal position or relaxed (0) Uneasy, restless, tense (1) Kicking, legs drawn up (2) -Activity: Lying quietly, normal position, moves easily (0) Squirming, shifting back and forth, tense (1) Arched, rigid or jerking (2) -Cry: No crying (awake or asleep) (0) Moans or whimpers, occasional complaint (1) Crying steadily, screamsor sobs, frequent complaints (2) -Consolability: Content, relaxed (0) Reassured by occasional touching, hugging or talking to, distractable (1) Difficult to console or comfort (2) The scale range from 0 to 10. The higher the number the worse the pain status.
  • Rescue analgesia [ Time Frame: 24 hours ]
    Time needed for first rescue analgesia
  • Total dose of rescue analgesia in the first 24 hours postoperatively. [ Time Frame: 24 hours ]
    Total dose of rescue analgesia in the first 24 hours postoperatively. If pain persisted or recurred rectal diclophenac 1mg/kg. total dose measured in milligrams
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2021)
  • Incidence of wound complications [ Time Frame: 72 hours ]
    Incidence of wound infection or dehiscence, descirbed in the form of occured or not occured.
  • Incidence of postoperative nausea and vomiting [ Time Frame: 24 hours ]
    Incidence of postoperative nausea and vomiting discribed in the form of occured or not occured
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexamethasone & Ketamine as Adjuvants to Bupivacaine for Incisional Infiltration in Pediatric Abdominal Operations
Official Title  ICMJE A Comparative Study Between Dexamethasone and Ketamine as Adjuvants to Bupivacaine for Incisional Infiltration in Pediatric Abdominal Operations
Brief Summary The aim of this study is to compare the effects of both ketamine and dexamethasone on the duration and magnitude of analgesia when combined with bupivacaine for incisional infiltration in pediatric abdominal operations.
Detailed Description

Wound infiltration with local anaesthetics is a simple, effective and inexpensive means of providing good analgesia for a variety of surgical procedures without any major side-effects.

Patients and Methods Type of Study:Randomized, controlled, double-blind study.

Study Setting: Ain Shams university hospitals.

Study Period: 3months after approval of the ethical committee.

Study Population:

Inclusion Criteria:

Children of both sexes aged 1-8 years, ASA I-II, undergoing moderate to major abdominal operations.

Exclusion Criteria:

History of diabetes, cardiac or neurological disease Hypersensitivity to any of the drugs used in the study Risk of wound complications ( as infected wound, history of wound dehiscence, hypo-albuminaemia) Multiple incision sites Operations scheduled as day-case

Sample size: using PASS program version 15, setting alpha error at 5%and power at 80%. Based on previous studies the needed sample is 50 cases per group (total 150 patients).

Sampling Method: simple random sampling Children will be randomized into three groups 50 patients each.

  • Group I: Bupivacaine 0.25% 1ml/kg will be injected subcutaneously by the surgeon before wound closure.
  • Group II: In addition to bupivacaine, ketamine 1mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and ketamine will be administered using two separate syringes.
  • Group III: In addition to bupivacaine, dexamethasone 0.2mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and dexamethsone will be administered using two separate syringes.

Study Tools and Study Procedures:

In all groups, drugs will be prepared by the attending anesthesiologist and injected by the surgeon (both will be blinded to the procedure) Anesthetic technique In all children, anesthesia will be induced by sevoflurane or propofol 2mg/kg IV, fentanyl 2ug/kg, atracurium 0.5 mg/kg followed by endotracheal intubation and mechanical ventilation with pressure controlled mode. Anesthesia will be maintained with sevoflurane in oxygen. All children will be monitored using ECG, non invasive blood pressure cuff, pulse oximeter and temperature probe. Ringer acetate will be used as the replacement fluid. At conclusion of surgery, the trachea will be extubated after reversal of the muscle relaxant with neostigmine 0.05 mg/kg + atropine 0.02 mg/kg and the child transferred to the postanesthesia care unit.

Comparisons will be done between both groups as regards: time needed for first analgesic dose (primary outcome), The FLACC pain scale will be assesed over a 24hour period as follows: (table 1) in PACU, then 2 hourly for 12 hours then 4 hourly.),Total number of administrations of rescue analgesia in the first 24 hours postoperatively, incidence of wound complications over a 7 d period (secondary outcomes)

First analgesic dose:

If the FLACC scale was more than 3 either during intervals of FLACC recording or in between, intravenous paracetamol was provided at a dose of 15mg/kg then fixed around the clock every 6 hours.

Rescue analgesia If pain persisted or recurred rectal diclophenac 1mg/kg or ibuprophen in children in whom oral intake has been allowed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
a randomized, controlled, double blind study
Masking: Double (Participant, Investigator)
Masking Description:
Both the patient and the attending anesthesiologist will be blinded to the drugs injected (a randomized, controlled, double blind study)
Primary Purpose: Treatment
Condition  ICMJE Pediatric ALL
Intervention  ICMJE
  • Drug: Bupivacaine
    Bupivacaine 0.25% 1ml/kg will be injected subcutaneously by the surgeon before wound closure.
  • Drug: Ketamine
    In addition to bupivacaine, ketamine 1mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and ketamine will be administered using two separate syringes.
  • Drug: Dexamethasone
    In addition to bupivacaine, dexamethasone 0.2mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and dexamethsone will be administered using two separate syringes.
Study Arms  ICMJE
  • Active Comparator: Group 1
    Control Group (Bupivacaine 0.25% 1ml/kg will be injected subcutaneously by the surgeon before wound closure).
    Intervention: Drug: Bupivacaine
  • Active Comparator: Group 2
    Ketamine Group (In addition to bupivacaine, ketamine 1mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and ketamine will be administered using two separate syringes).
    Interventions:
    • Drug: Bupivacaine
    • Drug: Ketamine
  • Active Comparator: Group 3
    Dexamethasone Group (In addition to bupivacaine, dexamethasone 0.2mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and dexamethsone will be administered using two separate syringes).
    Interventions:
    • Drug: Bupivacaine
    • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2021)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 15, 2021
Actual Primary Completion Date March 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children of both sexes aged 1-8 years, ASA I-II, undergoing moderate to major abdominal operations.

Exclusion Criteria:

  • History of diabetes, cardiac or neurological disease
  • Hypersensitivity to any of the drugs used in the study.
  • Risk of wound complications ( as infected wound, history of wound dehiscence, hypo--albuminaemia)
  • Multiple incision sites
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05190952
Other Study ID Numbers  ICMJE FMASU R 122A/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Diaaeldein Mahmoud Haiba, Ain Shams University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ain Shams University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP