Analgesic AffectPhase 3NCT00250692
A Study to Test the Pain-relieving Effect of Laughing Gas in Infants
A Phase 3 study testing Nitrous Oxide in people with Analgesic Affect, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Our proposal is to study infants in the Neonatal Intensive Care Unit (NICU) who are undergoing a heel stick for blood sampling, a standard procedure in patient care. Currently, these infants do not get any pain relief for this procedure. Read more about this study
- Who is it for?
- Ages 1 minute to 3 months
- Conditions the study is for
- Analgesic Affect
- What is being tested?
- Nitrous Oxide
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 3 months
- All sexes
- Child
Who may be able to join
- Full-term babies up to three months old scheduled for heel stick blood draw.
Who cannot join
- preterm, difficult airway (micrognathia, cranio-facial malformation, choanal atresia, Pierre Robin syndrome, or Treacher Collins syndrome), sedated, intubated (including tracheostomy), have an oxygen requirement (FiO2>40%), anemia, bone marrow suppression, or cardiac defect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of Nitrous Oxide in Neonates Undergoing Heel Stick
Our proposal is to study infants in the Neonatal Intensive Care Unit (NICU) who are undergoing a heel stick for blood sampling, a standard procedure in patient care. Currently, these infants do not get any pain relief for this procedure. Several recent clinical studies have shown the usefulness of nitrous oxide (laughing gas) for treating pain for minor procedures in children 0 to 18 years, but these effects have not been exclusively studied in the newborn and infant populations. Animal studies have questioned the anti-nociceptive (pain-blocking) effect of nitrous oxide in very young animals. It is unclear if this also applies to humans. The reason for this difference may be due to an immaturity of the neural pathways that modulate pain in the very young. The purpose of this study is to investigate whether or not nitrous oxide has an analgesic (pain-relieving) effect in infants undergoing minor procedures in the neonatal period (less than 3 months).
- Conditions
- Analgesic Affect
- Being tested
- Nitrous Oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
NIPS scale
salivary cortisol level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
Why it stopped: unknown - no record of study conduct in departmental archive
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic AffectStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Investigators
- Samuel Wald, MD, Principal investigator, UCLA Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250692
- Sponsor's protocol ID
- 05-04-029-01
- Status last verified
- Feb 2017
- First submitted
- 7 Nov 2005
- Last updated
- 17 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Nitrous Oxide in Neonates Undergoing Heel Stick
- ClinicalTrials.gov ID
- NCT00250692
- Acronym / sponsor ID
- 05-04-029-01
- Conditions
- Analgesic Affect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unknown - no record of study conduct in departmental archive
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- First posted
- 8 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our proposal is to study infants in the Neonatal Intensive Care Unit (NICU) who are undergoing a heel stick for blood sampling, a standard procedure in patient care. Currently, these infants do not get any pain relief for this procedure. Several recent clinical studies have shown the usefulness of nitrous oxide (laughing gas) for treating pain for minor procedures in children 0 to 18 years, but these effects have not been exclusively studied in the newborn and infant populations. Animal studies have questioned the anti-nociceptive (pain-blocking) effect of nitrous oxide in very young animals. It is unclear if this also applies to humans. The reason for this difference may be due to an immaturity of the neural pathways that modulate pain in the very young. The purpose of this study is to investigate whether or not nitrous oxide has an analgesic (pain-relieving) effect in infants undergoing minor procedures in the neonatal period (less than 3 months).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 1 minute to 3 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Full-term babies up to three months old scheduled for heel stick blood draw.
Key exclusion criteria (1 listed)
- preterm, difficult airway (micrognathia, cranio-facial malformation, choanal atresia, Pierre Robin syndrome, or Treacher Collins syndrome), sedated, intubated (including tracheostomy), have an oxygen requirement (FiO2>40%), anemia, bone marrow suppression, or cardiac defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous Oxide | Drug | – |
Primary outcome
NIPS scale
salivary cortisol level
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Wald, MD principal investigator
UCLA Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitrous Oxide in people with Analgesic Affect, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIPS scale. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.