## Protocol Section
### Identification Module
**NCT ID:** NCT06423820

**Brief Title:** Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries

**Official Title:** Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 36264PR640/4/24
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tanta University

#### Responsible Party

**Investigator Affiliation:** Tanta University

**Investigator Full Name:** Mohammed Said ElSharkawy

**Investigator Title:** Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The aim of this study is to evaluate the role of ondansetron lozenge on prevention of postoperative nausea and vomiting (PONV) in pediatrics undergoing squint surgeries.

**Detailed Description:** Post-operative nausea and vomiting (PONV) are two of the most common and distressing complications related to surgery and anesthesia.

In several studies PONV occurred in 13% to 42% of pediatric surgical patients, while severe cases are less common, occurring in 1-3% of patients. Volatile anesthetics are the main cause in the early post-operative period (0-2 h), with dose-response relationship. In the delayed post-operative period (2-24 h) the main predictors are childhood, PONV in the early period, and the use of postoperative opioids.

Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects.

### Conditions Module

**Conditions:**

- Ondansetron Lozenge

- Postoperative Nausea and Vomiting

- Pediatrics

- Squint

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group.

**Intervention Names:**

- Drug: Ondansetron lozenge

**Label:** Group S (Ondansetron lozenge)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Pediatric patients will not receive ondansetron as a control group.

**Label:** Group C (Control)

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group S (Ondansetron lozenge)

**Description:** Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.

**Name:** Ondansetron lozenge

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The incidence of postoperative nausea and vomiting (PONV) will be measured in the first 24 postoperative hours at the intervals of 0-2h (early PONV), 2-12h (delayed PONV), and 12- 24h (late PONV)

**Measure:** Incidence of postoperative nausea and vomiting

**Time Frame:** 24 hours postoperatively

#### Secondary Outcomes

**Description:** The severity of postoperative nausea and vomiting (PONV) will be scored as follows: \[0 = no nausea and no retching; 1 complaining of sickness and retching; vomiting one or two times in 30 min; and 3 vomiting more than two times in 30 min\] in the first 24 hours postoperatively.

**Measure:** Severity of postoperative nausea and vomiting (PONV)

**Time Frame:** 24 hours postoperatively

**Description:** Number of emetic episodes will be measured from the end of surgery till 24 hours postoperatively.

**Measure:** Number of emetic episodes

**Time Frame:** 24 hours postoperatively

**Description:** Time to onset of emesis will be measured from the end of surgery till 24 hours postoperatively.

**Measure:** Time to onset of emesis

**Time Frame:** 24 hours postoperatively

**Description:** Incidence of oculo-cardiac reflex (OCR) will be recorded. OCR is defined as a 10-20% decrease in the resting heart rate and/or the occurrence of any arrhythmia.

**Measure:** Incidence of oculo-cardiac reflex (OCR)

**Time Frame:** 24 hours postoperatively

**Description:** Degree of parental satisfaction by using an 11-pointverbal numeric scoring system (0 = not at all satisfied, 10 = fully satisfied).

**Measure:** Parental satisfaction

**Time Frame:** 24 hours postoperatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age from 4 to 15 years.
* American Society of Anesthesiology (ASA) physical status I, II.
* Pediatric patients undergoing squint surgeries.

Exclusion Criteria:

* Patients who had received any medication with antiemetic properties within 24 h before surgery.
* Post-operative period (for reasons other than rescue antiemetic therapy).
* Patients with known liver or renal disease.
* Patients with a history of vomiting or retching within 24 h before surgery.

**Maximum Age:** 15 Years

**Minimum Age:** 4 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mselsharkawy@med.tanta.edu.eg

**Name:** Mohammed S Elsharkawy, MD

**Phone:** 00201148207870

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tanta

**Contacts:**

***Contact 1:***

- **Email:** mselsharkawy@med.tanta.edu.eg

- **Name:** Mohammed S Elsharkawy, MD

- **Phone:** 00201148207870

- **Role:** CONTACT

***Contact 2:***

- **Name:** Saad A Moharam, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Tanta University

**State:** El-Gharbia

**Status:** RECRUITING

**Zip:** 31527

### IPD Sharing Statement Module

**Access Criteria:** The data will be available upon a reasonable request from the corresponding author.

**Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** After the end of study for one year.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000015835

- Term: Ocular Motility Disorders

- ID: D000003389

- Term: Cranial Nerve Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M12273

- Name: Nausea

- Relevance: HIGH

- As Found: Nausea

- ID: M17582

- Name: Vomiting

- Relevance: HIGH

- As Found: Vomiting

- ID: M22074

- Name: Postoperative Nausea and Vomiting

- Relevance: HIGH

- As Found: Postoperative Nausea and Vomiting

- ID: M16075

- Name: Strabismus

- Relevance: HIGH

- As Found: Squint

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M18386

- Name: Ocular Motility Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6605

- Name: Cranial Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013285

- Term: Strabismus

- ID: D000009325

- Term: Nausea

- ID: D000014839

- Term: Vomiting

- ID: D000020250

- Term: Postoperative Nausea and Vomiting

### Intervention Browse Module - Ancestors

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000000982

- Term: Antipruritics

- ID: D000003879

- Term: Dermatologic Agents

- ID: D000058831

- Term: Serotonin 5-HT3 Receptor Antagonists

- ID: D000012702

- Term: Serotonin Antagonists

- ID: D000018490

- Term: Serotonin Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19588

- Name: Ondansetron

- Relevance: HIGH

- As Found: Dual

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M29246

- Name: Serotonin 5-HT3 Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017294

- Term: Ondansetron

### Misc Info Module

- Version Holder: 2024-05-31
