Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00949104 |
| Other study ID # |
OGTPAIN |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
July 29, 2009 |
| Last updated |
July 29, 2009 |
| Start date |
January 2008 |
| Est. completion date |
April 2009 |
Study information
| Verified date |
July 2009 |
| Source |
Lady Hardinge Medical College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
India: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
RESEARCH HYPOTHESIS Orally administered sucrose 2 minutes prior to the procedure of OGT
insertion reduces pain associated with the procedure.
AIMS AND OBJECTIVES:
To study the effect of 24% oral sucrose on decreasing the painful response to orogastric
tube insertion .
Description:
MATERIAL & METHODS
PARTICPANTS:
INCLUSION CRITERIA: The enrolled participants must fulfill the following inclusion criteria:
- All pre-terms ( < 37 weeks of gestational age.)
- Within the first 7 days postnatal days (
- Clinically stable from respiratory, hemodynamic and metabolic point of view.
- Who have not received any painful stimulus at least 30 minutes prior to the
intervention.
- Requiring routine orogastric tube insertion within the first 7 days of life.
- Only the first attempt at putting OGT in controlled NICU environment will be considered
EXCLUSION CRITERIA: The neonates with the following characteristics will be excluded from
the study:
- Neonates requiring ventilatory support.
- Neonates requiring oxygen supplementation.
- Having any facial congenital anomalies.
- Having any neurological impairment.
- Receiving opiates or born to mothers receiving opiates.
- New born babies to whom muscle relaxants, sedatives and analgesics have been
administered.
- With grade 3 and 4 IVH.
- With major congenital anomalies
- Any history of birth trauma especially involving face or scalp (including
cephalhematoma/ subgaleal bleed).
- Face presentation.
INTERVENTIONS:
There will be two groups in the study ( group A & group B). The enrolled neonates will be
administered either a sterile solution of 24% sucrose or double distilled water orally.
These solutions will be prepared under all sterile precautions by the laboratory staff
unrelated to the study, and packed in 2 ml sterile syringes further covered with opaque
sealed envelopes bearing serially numbered patient codes. The composition of these packets
would be decided by a senior consultant in the department of pharmacology who would have the
access to the randomization sequence and would be uninvolved in the present study. Fresh
solutions will be prepared daily and unused solutions will be discarded at the end of the
day to be replaced with identically numbered solutions from the laboratory. All study
solutions will be stored in the refrigerator at 2-8 0C until they are used.
The patients will be enrolled into the study only after an informed written consent has been
obtained from either of the parent/ caregiver. 2 minutes prior to procedure, 1 ml of the
solution marked with patients's serial number will be administered orally to the patient by
a nurse using the syringe. The procedure would involve putting a 5-6 Fr. OGT in the neonate
which will be done by a group of 8-10 nurses who have been specially trained in this
procedure. This insertion of OGT will be done 2 min post administration of test solution by
a nurse who will be blinded to the contents of the solution.
The whole procedure (beginning 2 minutes before the OGT insertion and continuing till 4
minutes after it is inserted) will be video recorded on a fixed camera focusing on the face
of the patient. Neonate will be monitored using a non invasive vital signs monitor to
monitor his heart rate and SpO2 changes during the entire procedure and for 2 minutes post
procedure. The highest heart rate and lowest SpO2 obtained during the procedure till 2
minutes post procedure will be recorded. The research candidate will evaluate the pain
response to the procedure according to the PIPP scale at time t=pre-procedure,
t=intra-procedure,t=post 30 sec, t=post 1min, & t=post 2 min; wherein t denotes the time at
which tube is inserted into the oral cavity. The research candidate will also monitor the
time taken in the OGT insertion using a stopwatch. The neonatal nurse putting the OGT will
rate the procedure as easy, difficult or very difficult.
OUTCOMES:
PRIMARY OUTCOME: Painful response, as assessed by the PIPP scale. SECONDARY OUTCOME: Maximum
heart rate and minimum oxygen saturation recorded during the procedure.
SAMPLE SIZE CALCULATION:The sample size was calculated based on the assumption that there
would be a decrease of at least 20% in the pain scores in the study population with the
intervention and using a alpha error of 0.05 and a power of 90% the sample size was
calculated to be 55 each in both the groups ie a total of 110 neonates.
RANDOMISATION:Block Randomisation using computer generated random sequences with a block
size of 4 each.
SEQUENCE GENERATION:
Block randomization using computer generated random sequences will be used.
ALLOCATION CONCEALMENT:
This will be done by the pharmacy who will pack the sucrose and the double distilled water
(control/placebo) into identical containers and opaque sealed envelopes sequentially labeled
according to randomization code.
IMPLEMENTATION:
Randomization sequence will be generated by a senior consultant in the department of
pharmacology .The participants will be enrolled for the study by the candidate according to
the serial number as the candidate will be blinded.
BLINDING:
The participants, the research candidate,the nursing staff administering the intervention as
well as the investigators assessing the painful response will be blinded to the group
assignment
STATISTICAL METHODS: Descriptive statistics will be calculated.Between groups comparison of
continuous variables will be done with the help of t test for parametric data and by Mann
Whitney test for non parametric data.The proportion and frequencies will be calculated using
the chi square test.
