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

NCT05190952 | Completed

• 1 other identifier: FMASU R 122A/2020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric ALL

Keywords

bupivacine; Ketamine; dexamethasone

Outcome Measures

Primary Outcomes (6)

• The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale

  -Face: No particular expression or smile (0) Occasional grimace or frown, withdrawn, disinterested (1) Frequent to constant frown, clenched jaw, quivering chin (2) -Legs: Normal position or relaxed (0) Uneasy, restless, tense (1) Kicking, legs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.

  At Time zero (The time of extubation)

• The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale

  -Face: No particular expression or smile (0) Occasional grimace or frown, withdrawn, disinterested (1) Frequent to constant frown, clenched jaw, quivering chin (2) -Legs: Normal position or relaxed (0) Uneasy, restless, tense (1) Kicking, legs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.

  At 2 hours postoperatively

• The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale

  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.

  At 12 hours postoperatively

• The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale

  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.

  At 24 hours postoperatively

• Rescue analgesia

  Time needed for first rescue analgesia

  24 hours

• Total dose of rescue analgesia in the first 24 hours postoperatively.

  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

  24 hours

Secondary Outcomes (2)

• Incidence of wound complications

  72 hours

• Incidence of postoperative nausea and vomiting

  24 hours

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Control Group (Bupivacaine 0.25% 1ml/kg will be injected subcutaneously by the surgeon before wound closure).

Drug: Bupivacaine

Group 2

ACTIVE COMPARATOR

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).

Drug: Bupivacaine; Drug: Ketamine

Group 3

ACTIVE COMPARATOR

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).

Drug: Bupivacaine; Drug: Dexamethasone

Interventions

Bupivacaine DRUG

Bupivacaine 0.25% 1ml/kg will be injected subcutaneously by the surgeon before wound closure.

Group 1; Group 2; Group 3

Ketamine DRUG

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 2

Dexamethasone DRUG

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.

Group 3

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university hospitals

Cairo, Al Abbassia, 11591, Egypt

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Bupivacaine; Ketamine; Dexamethasone

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the patient and the attending anesthesiologist will be blinded to the drugs injected (a randomized, controlled, double blind study)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, ICU & Pain management, Faculty of medicine

Model Details: a randomized, controlled, double blind study

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: December 5, 2020
• Primary Completion: March 5, 2021
• Study Completion: April 15, 2021
• Last Updated: January 13, 2022

Record last verified: 2021-12

Locations

EG (1)