| CTRI Number |
CTRI/2022/06/043291 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of early feeding after anesthesia in children undergoing surgery. |
|
Scientific Title of Study
|
The impact of early postoperative oral hydration in paediatric patients undergoing elective surgery after general anaesthesia. A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mridul Dhar |
| Designation |
Assistant Professor, Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mridul Dhar |
| Designation |
Assistant Professor, Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mridul Dhar |
| Designation |
Assistant Professor, Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, AIIMS Rishikesh, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
Mridul Dhar |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Uttarakhand, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mridul Dhar |
Department of Anaesthesiology, Level 6, OT complex. AIIMS Rishikesh |
Department of Anaesthesiology, Level 6, OT complex. AIIMS Rishikesh
Dehradun
UTTARANCHAL |
9717778374
mriduldhar87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q189||Congenital malformation of face and neck, unspecified, (2) ICD-10 Condition: Q559||Congenital malformation of male genital organ, unspecified, (3) ICD-10 Condition: Q799||Congenital malformation of musculoskeletal system, unspecified, (4) ICD-10 Condition: Q349||Congenital malformation of respiratory system, unspecified, (5) ICD-10 Condition: Q649||Congenital malformation of urinarysystem, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early hydartion |
If Aldrete score is more than 9 and patient also has normal swallowing reflex, vocalization and stable vitals hydration will be given within 30 minutes of arrival to PACU |
| Comparator Agent |
Standard delayed hydration |
Hydration will be given after 2 hours (either in PACU or in the ward) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-II status undergoing elective surgery general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Preoperative URTI,
2. Respiratory infections,
3. Facial, oropharangeal, thoracic, GI, neuro or laryngeal surgeries,
4. altered mental status,
5. Dysphagia,
6. Patients with untrustworthy psychiatric problems,
7. Patient refusal,
8. Child refusal to accept hydration at the time of intervention. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FLACC score |
1. At arrival in PACU
2. One hour after arrival in PACU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Complications
2.Parent satisfaction score (1- 10) |
1. During PACU stay
2. After one hour of PACU stay |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2022 |
| Date of Study Completion (India) |
31/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Justification for study-
Pediatric patients are more prone for postoperative complications due
to fear, hunger and thirst. They have very different physiological and
psychological characteristics as compared to adults. Crying and agitation
during postoperative period may cause airway spasm, severe hypoxemia leading
to respiratory depression and apnoea, accidental falls and other adverse
events. Therefore, it represents a safety concern in postoperative period and
important for proper nursing of the child [1].
To
prevent postoperative coughing, vomiting and aspiration risk,
early feeding or oral hydration was not administered. But now it was found
that early oral feeding and hydration to be beneficial and safe. The optimal
time period for such administration of feeds and fluids is unclear, therefore,
through this study we want to observe the impact of early oral feeding in
children in postoperative period.
Hypothesis: Compared to standard delayed hydration, early hydration in
paediatric patients undergoing elective surgery after general anaesthesia
will produce decrease in post
operative FLACC score with no increase in incidence of complications.
|
|