1. Paucity of local literature about neonatal circumcision with or without Anaesthesia.
2. The study therefore relied on work done in centers outside Africa.
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APPENDIX A: CONSENT FORM.
Dear Parents.
I’m, Dr. Aminu Fikin, a resident Doctor in Family Medicine Department of Plateau State Specialist Hospital, Jos, conducting a study to assess pain with or without aneasthesia during neonatal circumcision using the Neonatal infant pain scale [NIPS].The infants will be randomized to circumcision either with or without anaesthesia. If you agree to participate in this study, I will carry out the following:-
1. Ask questions about the demographic data of the child.
2. Perform clinical examination including the weighing of the child.
3. Perform the circumcision by using clamps or a plastibell device.
4. Any information given will be treated as confidential even after the study has ended.
5. The surgery will cause some pains to your child but I will be gentle as possible.
Participation in the study will not add to the cost of treatment of your child.
Your child’s participation is voluntary and you reserve the right to decline. Withdrawal will not affect your child’s treatment. However, I solicit your co-operation to enable me obtain meaningful results. All information collected for this study will be kept confidential.
I willingly agree for my child to participate in this study.
Study No. of the Baby ____________________
Signature or Thumbprint of father/mother ___________
Name/ Signature of the witness/Date _______________
APPENDIX B: QUESTIONNAIRE
A. General Data.
1. Study No.____________2. Hosp. No._________________3.Date______________
4. Age ___________ 5. Informant____________ 6. Reason for the circumcision________
B. Socio-demographic characteristics of the parents.
1. Occupation of:
a) Father ____________
b) Mother____________
2. Religion of:
a) Father____________
b) Mother___________
3. Ethnicity of:
a) Father________
b) Mother_________
a) Father__________
b) Mother_______
5. Marital status of the mother
a) Married: __________________________
b) Single: ____________________________
c) Divorced/Separated: ________________________
d) Widow: _______________________________________
C. Physical examination.
1. Heart rate_______________________________________________________
2. Respiratory rate___________________________________
3. Breathing pattern___________________________________
4. Oxygen saturation____________________________________
5. Length [cm] __________ Head circumference [cm] ______________
6. Weight_______________
8. Duration________________________________
D. COMPLICATIONS.
a).Immediate (from the time of surgery to one hour after the surgery) __ b).Late ______________
APPENDIX C: NEONATAL/INFANT PAIN SCALE (NIPS) Neonatal/Infant Pain Scale (NIPS) 17 (Modified)
(Recommended for children less than 1 year old) - A score greater than 3 indicates pain.
Pain Assessment Score
Facial Expression
0 – Relaxed muscles Restful face, neutral expression
1 – Grimace Tight facial muscles; furrowed brow, chin, jaw, (negative facial expression – nose, mouth and brow)
Cry
0 – No Cry Quiet, not crying
1 – Whimper Mild moaning, intermittent
2 – Vigorous Cry Loud scream; rising, shrill, continuous (Note: Silent cry may be scored if baby is intubated as evidenced by obvious mouth and facial movement.
Breathing Patterns
0 – Relaxed Usual pattern for this infant
1 – Change in
Breathing In drawing, irregular, faster than usual; gagging; breath
holding
Arms
0 –
Relaxed/Restrained No muscular rigidity; occasional random movements of arms 1 – Flexed/Extended Tense, straight legs; rigid and/or rapid extension, flexion
Legs
0 –
Relaxed/Restrained No muscular rigidity; occasional random leg movement 1 – Flexed/Extended Tense, straight legs; rigid and/or rapid extension, flexion
State of Arousal
0 – Sleeping/Awake Quiet, peaceful sleeping or alert random leg movement
1 – Fussy Alert, restless, and thrashing
N.B. Legs movement will be excluded because the infant will be restrained on theatre bed
APPENDIX D: ETHICAL CLEARANCE