Premedication for preventing pain in infants undergoing non‐urgent breathing tube placement
| ISRCTN | ISRCTN13875422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13875422 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Children’s Hospital of Nanjing Medical University |
| Funders | Project of Futang Children's Science Foundation (FTCSF-2018-04), Nanjing Special Fund for Health Science and Technology Development (grant no. 201723007) |
- Submission date
- 10/09/2022
- Registration date
- 12/10/2022
- Last edited
- 12/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Endotracheal intubation is a medical procedure in which a tube is placed into the windpipe through the mouth or nose. It may cause discomfort and pain, as well as harmful physiological reactions. Analgesics have been found to relieve pain caused by endotracheal intubation. The aim of this study is to evaluate the analgesic effect of combined administration before non-emergency endotracheal intubation in infants.
Who can participate?
Infants in the neonatal intensive care unit at Children’s Hospital of Nanjing Medical University who require endotracheal intubation
What does the study involve?
Infants are randomly assigned to experimental and control groups. The experimental group are injected with 5% glucose 2 ml + atropine 0.02 mg/kg (1 min) and 5% glucose 2 ml and fentanyl 2 ug/kg (5 min) before endotracheal intubation. The control group are injected with 5% glucose 2 ml (1 min) and 5% glucose 2 ml (5 min) before endotracheal intubation. The degree of pain during the examination is recorded.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved in taking part in this study.
Where is the study run from?
Children’s Hospital of Nanjing Medical University (China)
When is the study starting and how long is it expected to run for?
March 2017 to March 2022
Who is funding the study?
Children’s Hospital of Nanjing Medical University (China)
Who is the main contact?
Dr Keyu Lu, lukeyu19892001@sina.com
Contact information
Principal investigator
Guangzhou Road 72
Nanjing
210009
China
| Phone | +86 (0)8613951703146 |
|---|---|
| lukeyu19892001@sina.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter interventional double-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effectiveness of fentanyl and atropine for premedication of the newborn infant before non-emergency endotracheal intubation: a randomized controlled trial |
| Study acronym | PBNEEI |
| Study objectives | Fentanyl and atropine might decrease the pain response during non‐urgent endotracheal intubation in neonates |
| Ethics approval(s) | Approved 25/05/2017, Children’s Hospital of Nanjing Medical University Ethics Committee (72 Guangzhou Road, Nanjing, China; +86 (0)83117281; nanjingnicu@163.com), ref: #201703069 |
| Health condition(s) or problem(s) studied | Premedication for non‐urgent endotracheal intubation for preventing pain in neonates with respiratory failure |
| Intervention | The research team comprised three research neonatologists, a child health care expert, and three assistants with extensive research and clinical experience. Following the acquisition of informed consent from the guardians, the infants were randomly assigned to either the experimental group or the control group using a computer-generated randomization code. Subjects and intubators are blinded. The experimental group are intravenously injected with 5% glucose 2 ml + atropine 0.02 mg/kg (1 min) and 5% glucose 2 ml + fentanyl 2 ug/kg (5 min) successively before endotracheal intubation. The control group are intravenously injected with 5% glucose 2 ml (1 min) and 5% glucose 2 ml (5 min) successively before endotracheal intubation. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Fentanyl, atropine |
| Primary outcome measure(s) |
1. Behavioural responses measured using the N-PASS score at the time of intubation |
| Key secondary outcome measure(s) |
1. Conditions of endotracheal intubation (difficulty of intubation, the opening and closing state of the glottis, and the children's response to intubation) evaluated using the modified Goldberg score at the time of intubation |
| Completion date | 01/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 80 |
| Key inclusion criteria | Children with indications for endotracheal intubation, intravenous access or time to open intravenous access, and able to complete intubation within 15-30 minutes |
| Key exclusion criteria | 1. Children with emergency intubation 2. Structural abnormalities of the upper respiratory tract (e.g. Pierre-Robin syndrome, glottic stenosis) 3. Upper digestive tract malformation (such as diaphragmatic hernia) 4. A history of difficulty in endotracheal intubation 5. Central respiratory failure caused by asphyxia or brain injury 6. Children intubated twice or more during treatment |
| Date of first enrolment | 30/06/2017 |
| Date of final enrolment | 30/06/2020 |
Locations
Countries of recruitment
- China
Study participating centres
Nanjing
210009
China
Dao li District
Harbin
150010
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/10/2022: Trial's existence confirmed by the Children’s Hospital of Nanjing Medical University Ethics Committee.
