How effective is Ametop 4% gel, before a venipuncture, at reducing procedural pain in infants: a randomized placebo-controlled trial
| ISRCTN | ISRCTN42842643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42842643 |
| Secondary identifying numbers | BL 002 |
- Submission date
- 29/07/2005
- Registration date
- 04/11/2005
- Last edited
- 27/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Brigitte Lemyre
Scientific
Scientific
401 Smyth Road
Ottawa
K1H 8L1
Canada
| blemyre@ottawahospital.on.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | How effective is Ametop 4% gel, before a venipuncture, at reducing procedural pain in infants: a randomized placebo-controlled trial |
| Study hypothesis | Amethocaine 4% gel applied before a venipuncture in newborn infants will safely and significantly decrease procedural pain |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Procedural pain |
| Intervention | Ametop (amethocaine) 4% gel versus placebo, 1.5 g applied to skin for 30 minutes prior to the venipuncture |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ametop (amethocaine, tetracaine hydrochloride) 4% gel |
| Primary outcome measure | Premature Infant Pain Profile (PIPP) score in the first minute after skin puncture |
| Secondary outcome measures | 1. PIPP scores during the first, second, third and fourth minute post-skin puncture 2. Mean heart rate in beats per minute, mean respiratory rate per minute, mean blood pressure in mm Hg and mean 02 saturation in % at the end of baseline, 1 minute after skin puncture then 2, 3, 4, 5 and 10 minutes after skin puncture 3. Duration of cry, from skin puncture to recovery 4. Ease of procedure, as reflected by the mean number of attempts required to obtain the bloodwork, the success rate at obtaining the bloodwork and subjective measure of easiness on a scale of 1 to 5 (1 being very easy and 5 very hard) The safety of amethocaine was assessed using the following data: local skin reaction (redness, edema), complete blood count and differential (pre and post intervention), aspartate aminotransferase (AST) and ALT (pre and post intervention), and creatinine levels (post intervention). All infants’ vital signs were monitored throughout and after the intervention and any significant event (apnea/bradycardia, sustained bradycardia or tachycardia, sustained desaturation requiring intervention) was recorded. |
| Overall study start date | 03/01/2003 |
| Overall study end date | 30/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 54 |
| Total final enrolment | 142 |
| Participant inclusion criteria | 1. Born at >24 weeks gestation 2. Skin considered in good condition (no burns or rash) 3. If <27 weeks gestation, at least 48 hours of life 4. Considered stable by the treating neonatologist |
| Participant exclusion criteria | 1. Skin considered immature (insensible water losses requiring more fluids than usual for gestation) 2. Suspected or proven significant central nervous system anomaly 3. Receiving opioids or sedatives at time of venipuncture or in the previous 12 hours or receiving muscle relaxants 4. Facial anomalies (cleft lip/palate, Moebius syndrome) preventing typical facial expression of pain 5. Sub optimal hepatic function (alanine aminotransferase [ALT] >2 x upper normal limit) or sub optimal renal function (urine output <1 ml/kg/hour in the last 12 hours) |
| Recruitment start date | 03/01/2003 |
| Recruitment end date | 30/12/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
401 Smyth Road
Ottawa
K1H 8L1
Canada
K1H 8L1
Canada
Sponsor information
Children's Hospital of Eastern Ontario Research Institute (Canada)
Hospital/treatment centre
Hospital/treatment centre
401 Smyth Road
Ottawa
K1H 8L1
Canada
| blemyre@ottawahospital.on.ca | |
"ROR" |
https://ror.org/05nsbhw27 |
Funders
Funder type
Hospital/treatment centre
Physicians Services Incorporated (#02-39) and Children's Hospital of Eastern Ontario Research Institute
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/02/2007 | 27/10/2022 | Yes | No |
Editorial Notes
27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
