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

Pediatric ALL Clinical Trial

Official title:

A Comparative Study Between Dexamethasone and Ketamine as Adjuvants to Bupivacaine for Incisional Infiltration in Pediatric Abdominal Operations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190952
• Other study ID #: FMASU R 122A/2020
• Status: Completed
• Phase: N/A
• Start date: December 5, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: December 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 15, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric ALL

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams university hospitals	Cairo	Al Abbassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	Rescue analgesia	Time needed for first rescue analgesia	24 hours
Primary	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	Incidence of wound complications	Incidence of wound infection or dehiscence, descirbed in the form of occured or not occured.	72 hours
Secondary	Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting discribed in the form of occured or not occured	24 hours