## Protocol Section
### Identification Module
**NCT ID:** NCT02571179

**Acronym:** fentaobs

**Brief Title:** Intranasal Fentanyl in Treatment of Labour Pain

**Official Title:** Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety

#### Organization Study ID Info
**ID:** KUH12_04_2010
#### Organization
**Class:** OTHER
**Full Name:** Kuopio University Hospital
### Status Module
#### Completion Date
**Date:** 2021-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-16

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-03

**Type:** ACTUAL

#### Start Date
**Date:** 2011-01

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2015-10-08
**Type:** ESTIMATED
**Study First Submit Date:** 2015-10-05
**Study First Submit QC Date:** 2015-10-07
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Admescope Ltd

#### Lead Sponsor

**Class:** OTHER

**Name:** Kuopio University Hospital

#### Responsible Party

**Investigator Affiliation:** Kuopio University Hospital

**Investigator Full Name:** Merja Kokki

**Investigator Title:** MD, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Physiological changes during pregnancy are known to affect the pharmacokinetics of many drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in pregnant patients has not been established. The investigators studied pharmacokinetics of intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal safety after administration.

### Conditions Module

**Conditions:**

- Labor Pain

**Keywords:**

- Labor pain

- Fentanyl

- Transmucosal

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Intranasal fentanyl

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patient was given intranasal fentanyl 50 microg/dose up to 250 microg

**Intervention Names:**

- Drug: intranasal fentanyl 50 microg dose up to 250 microg

**Label:** Intranasal fentanyl 50 microg/dose

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intranasal fentanyl 50 microg/dose

**Description:** When contraction pain was ≥ 5/10 (numerical rating scale 0= no pain, 10= worst pain), the parturient was given a intranasal fentanyl 50 µg dose. After 15 minutes, if contraction pain was still ≥ 5/10, a second 50 µg intranasal dose was administered. Fentanyl was administered every 15 minute until contraction pain decreased to less than 5/10 or until the maximum fentanyl dose of 250 µg was administered.

**Name:** intranasal fentanyl 50 microg dose up to 250 microg

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Fentanyl maximum concentration

**Time Frame:** From the first intranasal fentanyl dose to birth of the newborn up to 48 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* healthy parturients with uncomplicated, single gestation pregnancies, full term (38-42 weeks of gestation) pregnancy, agreed to participate

Exclusion Criteria:

* a disease that might affect hepatic or renal function, contraindications to opioid analgesics, fetal growth retardation, signs of fetal asphyxia by cardiotocography, meconium stained amniotic fluid or placental insufficiency. The subjects should not have received fentanyl during the previous 14 days.

Not agreed to participate

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kuopio

**Country:** Finland

**Facility:** Kuopio University Hospital

**State:** Northern Savo

**Zip:** 70029

#### Overall Officials

**Official 1:**

**Affiliation:** Kuopio University Hospital, Kuopio, Finland

**Name:** Merja Kokki, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M26008

- Name: Labor Pain

- Relevance: HIGH

- As Found: Labor Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000048949

- Term: Labor Pain

### Intervention Browse Module - Ancestors

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000759

- Term: Adjuvants, Anesthesia

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

### Intervention Browse Module - Browse Branches

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M8418

- Name: Fentanyl

- Relevance: HIGH

- As Found: Moderate

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4089

- Name: Adjuvants, Anesthesia

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000005283

- Term: Fentanyl

### Misc Info Module

- Version Holder: 2024-05-24
