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IRCT20140820018883N1 IRCT 2018-02-21 Gorgan University of Medical Sciences Effectiveness of Oral 10% Glucose solution in reducing pain due to venipuncture in Infants 1month to 1 year Comparison of the Effectiveness of Oral 10% Glucose solution with placebo in reducing pain due to venipuncture in Infants 1month to 1 year 2018-04-04 anticipated 60 Complete https://irct.ir/trial/28588 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: To prevent researchers, Healthcare provider, and parents from predicting which infant will receive which solution (Placebo or intervention), we will conceal the allocation sequence by using opaque sealed envelopes. These contain the letters A (placebo) or B (Glucose). After obtaining informed consent from parents, they will be given an envelope to take with themselves to the treatment room, where the intervention will be applied. the researcher will open the envelope and based on the letters (A or B) will assign the infants into the groups. Two minutes before intervention the solution (Placebo or Intervention) will be feed to the infants and video recording will be started, Randomization description: The researcher will assign participants in two groups by using block randomization technique, Blinding description: The infant parents/ caregiver, the nurse responsible for intravenous catheterization (health care provider) and the persons (at least two) responsible for observing records and evaluating pain severity (Outcome assessors) will be blinded. In addition, we will conceal the intervention by using coded syringes (A and B) contain simple water (Placebo) and sweet solution with the same size, shape, and brand. N/A Condition 1: Venipuncture ŮŽacute pain in infants admitted to Emergency Department for acute diseases. Condition 2: Acute pain due to venipuncture. Intervention 1: Intervention group: Including Eligible infants between one month and one year old admitted to Emergency Department of Hospital. They will receive 2 milliliters 10% glucose solution, one time, 2 minutes before venipuncture, orally. The researcher will draw Glucose solution into the uniform 2 milliliters syringes and will be coded(A) at the beginning of each day. The solution will be prepared by a pharmacist based on the researcher order. Intervention 2: Control group: Including Eligible infants between one month and one year old admitted to Emergency Department of Hospital. They will receive 2 milliliters sterile water, one time, 2 minutes before venipuncture, orally. The researcher will draw sterile water into the uniform 2 milliliters syringes and encode(B) at the beginning of each day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Homeira Khoddam
Nursing and Midwifery School, Golestan university of medical sciences, Falsafi Educational Campus, Hircan BLV.
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 6900 khoddam@goums.ac.ir Gorgan University of Medical Sciences scientific Leila Barati
School of Medicine, Golestan university of medical sciences, Falsafi Educational Campus, Hircan BLV
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 0225 dr_l_barati@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) age:one month to one year old Need to indwelling catheter in Limb's'peripheral veins Candidate for Intravenous Fluid Therapy Informed consent of parents to participate the Infant 1 month 1 year Both Disturbed of consciousness Life threatening conditions (poisoning,..) Prevention Placebo Intervention group: Including Eligible infants between one month and one year old admitted to Emergency Department of Hospital. They will receive 2 milliliters 10% glucose solution, one time, 2 minutes before venipuncture, orally. The researcher will draw Glucose solution into the uniform 2 milliliters syringes and will be coded(A) at the beginning of each day. The solution will be prepared by a pharmacist based on the researcher order. Control group: Including Eligible infants between one month and one year old admitted to Emergency Department of Hospital. They will receive 2 milliliters sterile water, one time, 2 minutes before venipuncture, orally. The researcher will draw sterile water into the uniform 2 milliliters syringes and encode(B) at the beginning of each day. Pain severity. Timepoint: two minutes before to two minutes after painful procedure (Venipuncture). Method of measurement: FLACC (Face, Legs, Activity, Cry, CONSOLability) scoring system. Crying duration. Timepoint: from Intervention and two minute after that. Method of measurement: Observation and record by two independent observers. Gorgan University of Medical Sciences Approved 2018-01-28 Golestan University of Medical Sciences Research Ethical Committee. Hircan Boulvard. Gorgan Golestan Iran (Islamic Republic of)